Evaluation of Changes to Skin Microbiome With Tape-Stripp... | NCT03365934 | Trialant
NCT03365934
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
Status
Completed
Last Update Posted
Jun 4, 2019Actual
Enrollment
35Actual
Phase
Not Applicable
Conditions
Healthy Volunteers
Interventions
ADHESIVE BANDAGE #1
ADHESIVE BANDAGE #2
ADHESIVE BANDAGE #3
Antibacterial Bandage with 0.8% BZK
Intact and No Bandage
Wounded and No Bandage
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03365934
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CO-170726100607-SACT
Secondary IDs
Not provided
Brief Title
Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds
Official Title
Randomized, Exploratory Study to Evaluate Changes to Skin Microbiome With Tape-stripped Wounds
Acronym
Not provided
Organization
Johnson & Johnson Consumer and Personal Products WorldwideINDUSTRY
Status Module
Record Verification Date
May 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 20, 2017Actual
Primary Completion Date
Feb 12, 2018Actual
Completion Date
Feb 12, 2018Actual
First Submitted Date
Nov 16, 2017
First Submission Date that Met QC Criteria
Dec 1, 2017
First Posted Date
Dec 8, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Feb 11, 2019
Results First Submitted that Met QC Criteria
May 14, 2019
Results First Posted Date
Jun 4, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 14, 2019
Last Update Posted Date
Jun 4, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
Yes
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin physiology assessments will be completed.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy Volunteers
Keywords
Microflora
Microbiome
skin physiology
Fitzpatrick Skin Types I-III
Tape-stripped wounds
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
35Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ADHESIVE BANDAGE #1
Experimental
bandage applied to wounded site.
Device: ADHESIVE BANDAGE #1
ADHESIVE BANDAGE #2
Experimental
bandage applied to wounded site.
Device: ADHESIVE BANDAGE #2
ADHESIVE BANDAGE #3
Experimental
bandage applied to wounded site
Device: ADHESIVE BANDAGE #3
Antibacterial Bandage with 0.8% BZK
Experimental
bandage with 0.8% Benzalkonium Chloride (BZK) applied to wounded site
Device: Antibacterial Bandage with 0.8% BZK
Intact and No Bandage
Other
This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.
Other: Intact and No Bandage
Wounded and No Bandage
Other
This test site will be wounded and no bandage applied, serving as a positive control site.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ADHESIVE BANDAGE #1
Device
Bandage applied daily to wounded site for 14 days
ADHESIVE BANDAGE #1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Microbial Community Richness - Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) and analyzed to determine the total number of different bacterial taxa (microorganisms) detected in the sample. There was no prespecified primary endpoint in the protocol.
Baseline (Day 0)
Microbial Community Richness - (Day 1)
Swabs will be collected on the back at Day 1 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Day 1
Microbial Community Richness - (Day 2)
Swabs will be collected on the back at Day 2 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Day 2
Microbial Community Richness - (Day 3)
Swabs will be collected on the back at Day 3 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Day 3
Microbial Community Richness - (Day 4)
Swabs will be collected on the back at Day 4 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Day 4
Microbial Community Richness - (Day 5)
Swabs will be collected on the back at Day 5 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Day 5
Microbial Community Richness - (Day 6)
Secondary Outcomes
Measure
Description
Time Frame
Skin Barrier Function -Baseline (Day 0)
The skin barrier function of the test sites will be evaluated at Baseline (Day 0) by Trans Epidermal Water Loss (TEWL).
Day 0
Skin Barrier Function - Day 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adults aged 18 to 55 years of age.
Fitzpatrick skin types I to III.
Must be able to comprehend and follow the requirements of the study
Avoid excessive sun exposure
Willing to refrain from topical product use on the back for the duration of the study.
Subjects must agree not to immerse their bandages in water for the duration of the study.
Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control
Exclusion Criteria:
Excessively hairy back, acne, scars and pigmentation or nevi t
. Pregnant or Lactating, or planning on becoming pregnant;
. Known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes;
. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
Participation in any other clinical study within 30 days of Visit 1;
. Subjects who have a health condition and/or pre-existing or dormant dermatologic conditions or who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections
Subjects who report using prescription or OTC medication (oral or topical) that can make skin more sensitive or influence the skin (i.e. antibiotics, hormones, insulin, etc.)
Subjects receiving topical and/or inhaled medications that may alter or compromise the bleeding/healing process
Individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications and/or radiation
. Subjects with a known history of keloid or hypertrophic scar formation;
Subjects diagnosed with any blood clotting disorder;
Hyperthyroidism or hypothyroidism or with active or recently treated (within 1 year) skin cancer, or those in poor nutritional status; 13 Subjects taking oral Vitamin A derivatives such as Accutane, isotretinon, or using retinoic acid in the past 1 year or using topical Vitamin A derivatives in the 3 weeks prior to study start;
14. Subjects with clinically infected skin lesions; 15. Subjects with cracked or excoriated skin, or other skin problems. 16. Diabetes mellitus that cannot be controlled by diet alone (i.e. requires systemic medications for control); 17. Subjects with friable skin, at the discretion of the Investigator;
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Philip Lastella, MD
TKL Research, Inc.
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
TKL Research Inc.
Fair Lawn
New Jersey
07410
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
All Randomized Subjects
All Randomized Subjects
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00035 subjects
COMPLETED
FG00033 subjects
NOT COMPLETED
FG0002 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
Withdrawal by Subject
FG0001 subjects
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Randomized Subjects
All Randomized Subjects
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Microbial Community Richness - Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) and analyzed to determine the total number of different bacterial taxa (microorganisms) detected in the sample. There was no prespecified primary endpoint in the protocol.
Posted
Mean
95% Confidence Interval
Number of bacterial taxa
Baseline (Day 0)
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Adverse Events Module
Frequency Threshold
5
Time Frame
All adverse events were collected from the time the informed consent was obtained through the subject's last study procedure/visit. Serious adverse events were collected through and including 30 calendar days after administration of the subject's last dose or exposure to IP.
bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days
Antibacterial Bandage with 0.8% BZK
Intact and No Bandage
Other
This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.
Intact and No Bandage
Wounded and No Bandage
Other
This test site will be wounded but will not be treated with a bandage, serving as the positive control site.
Wounded and No Bandage
Swabs will be collected on the back at Day 6 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Day 6
Microbial Community Richness - (Day 7)
Swabs will be collected on the back at Day 7 and analyzed to determine the total number of different bacteria Taxa (microorganismss) detected in the sample.
Day 7
Microbial Community Richness - (Day 14)
Swabs will be collected on the back at Day 14 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Day 14
Microbial Community Diversity - Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Shannon Index.
Baseline (Day 0)
Microbial Community Diversity - Day 1
Swabs will be collected on the back at Day 1 for analysis based on the Shannon Index.
Day 1
Microbial Community Diversity - Day 2
Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.
Day 2
Microbial Community Diversity - Day 3
Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.
Day 3
Microbial Community Diversity - Day 4
Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.
Day 4
Microbial Community Diversity - Day 5
Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.
Day 5
Microbial Community Diversity - Day 6
Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.
Day 6
Microbial Community Diversity - Day 7
Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.
Day 7
Microbial Community Diversity - Day 14
Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.
Day 14
Microbial Community Evenness - Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Pielou's Evenness Index.
Day 0
Microbial Community Evenness - Day 1
Swabs will be collected on the back at Day 1 for analysis based on the Pielou's Evenness Index.
Day 1
Microbial Community Evenness - Day 2
Swabs will be collected on the back at Day 2 for analysis based on the Pielou's Evenness Index.
Day 2
Microbial Community Evenness - Day 3
Swabs will be collected on the back at Day 3 for analysis based on the Pielou's Evenness Index.
Day 3
Microbial Community Evenness - Day 4
Swabs will be collected on the back at Day 4 for analysis based on the Pielou's Evenness Index.
Day 4
Microbial Community Evenness - Day 5
Swabs will be collected on the back at Day 5 for analysis based on the Pielou's Evenness Index.
Day 5
Microbial Community Evenness - Day 6
Swabs will be collected on the back at Day 6 for analysis based on the Pielou's Evenness Index.
Day 6
Microbial Community Evenness - Day 7
Swabs will be collected on the back at Day 7 for analysis based on the Pielou's Evenness Index.
Day 7
Microbial Community Evenness - Day 14
Swabs will be collected on the back at Day 14 for analysis based on the Pielou's Evenness Index.
Day 14
The skin barrier function of the test sites will be evaluated at Day 1 by Trans Epidermal Water Loss (TEWL).
Day 1
Skin Barrier Function - Day 2
The skin barrier function of the test sites will be evaluated at Day 2 by Trans Epidermal Water Loss (TEWL).
Day 2
Skin Barrier Function - Day 3
The skin barrier function of the test sites will be evaluated at Day 3 by Trans Epidermal Water Loss (TEWL).
Day 3
Skin Barrier Function - Day 4
The skin barrier function of the test sites will be evaluated at Day 4 by Trans Epidermal Water Loss (TEWL).
Day 4
Skin Barrier Function - Day 5
The skin barrier function of the test sites will be evaluated at Day 5 by Trans Epidermal Water Loss (TEWL).
Day 5
Skin Barrier Function - Day 6
The skin barrier function of the test sites will be evaluated at Day 6 by Trans Epidermal Water Loss (TEWL).
Day 6
Skin Barrier Function - Day 7
The skin barrier function of the test sites will be evaluated at Day 7 by Trans Epidermal Water Loss (TEWL).
Day 7
Skin Barrier Function - Day 14
The skin barrier function of the test sites will be evaluated at Day 14 by Trans Epidermal Water Loss (TEWL).
Day 14
Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Day 0
Redness: Wound Area Oxyhemoglobin Level - Day 1
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Day 1
Redness: Wound Area Oxyhemoglobin Level - Day 2
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Day 2
Redness: Wound Area Oxyhemoglobin Level - Day 3
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Day 3
Redness: Wound Area Oxyhemoglobin Level - Day 4
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Day 4
Redness: Wound Area Oxyhemoglobin Level - Day 5
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Day 5
Redness: Wound Area Oxyhemoglobin Level - Day 6
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Day 6
Redness: Wound Area Oxyhemoglobin Level - Day 7
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Day 7
Redness: Wound Area Oxyhemoglobin Level - Day 14
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Day 14
35
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.5± 12.05
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00025
Male
BG00010
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
Asian
BG0000
Native Hawaiian or Other Pacific Islander
BG0000
Black or African American
BG0000
White
BG00035
More than one race
BG0000
Unknown or Not Reported
BG0000
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
North America
Title
Measurements
USA
BG00035
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00029
OG00122
OG00228
OG00327
OG00423
OG00527
Title
Denominators
Categories
Title
Measurements
OG00056.5862069(41.82700101 to 71.34541279)
OG00132.13043478(21.71828318 to 42.54258639)
OG00243.72413793(31.41567266 to 56.0326032)
OG00334.03703704(25.21769482 to 42.85637925)
OG00442.39130435(28.2925728 to 56.4900359)
OG00546.48148148(32.28761284 to 60.67535013)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.071225
Superiority
OG000
OG003
t-test, 2 sided
0.092027
Superiority
OG000
OG004
t-test, 2 sided
0.601716
Superiority
OG000
OG002
t-test, 2 sided
0.639911
Superiority
OG000
OG005
t-test, 2 sided
0.842476
Superiority
OG001
OG003
t-test, 2 sided
0.999941
Superiority
OG001
OG004
t-test, 2 sided
0.883479
Superiority
OG001
OG002
t-test, 2 sided
0.782208
Superiority
OG001
OG005
t-test, 2 sided
0.607134
Superiority
OG003
OG004
t-test, 2 sided
0.939549
Superiority
OG002
OG003
t-test, 2 sided
0.86475
Superiority
OG003
OG005
t-test, 2 sided
0.704759
Superiority
OG002
OG004
t-test, 2 sided
0.999989
Superiority
OG004
OG005
t-test, 2 sided
0.997568
Superiority
OG002
OG005
t-test, 2 sided
0.999518
Superiority
Primary
Microbial Community Richness - (Day 1)
Swabs will be collected on the back at Day 1 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Posted
Mean
95% Confidence Interval
Number of bacterial taxa
Day 1
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00032
OG00129
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG00053.15625(38.21010189 to 68.10239811)
OG00158.75862069(47.10408916 to 70.41315222)
OG00222(18.01079945 to 25.98920055)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.985332
Superiority
OG000
OG003
t-test, 2 sided
1
Primary
Microbial Community Richness - (Day 2)
Swabs will be collected on the back at Day 2 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Posted
Mean
95% Confidence Interval
Number of bacterial taxa
Day 2
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00032
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG00060.15625(45.95442154 to 74.35807846)
OG00187.03030303(64.50676969 to 109.5538364)
OG00220.33333333(15.69936368 to 24.96730299)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.027774
Superiority
OG000
OG003
t-test, 2 sided
0.08431
Primary
Microbial Community Richness - (Day 3)
Swabs will be collected on the back at Day 3 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Posted
Mean
95% Confidence Interval
Number of bacterial taxa
Day 3
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00029
OG00132
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG00053.44827586(40.61259145 to 66.28396027)
OG00174.03125(60.80846371 to 87.25403629)
OG00219.21212121(16.49174219 to 21.93250024)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.0403539
Superiority
OG000
OG003
t-test, 2 sided
0.2953049
Primary
Microbial Community Richness - (Day 4)
Swabs will be collected on the back at Day 4 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Posted
Mean
95% Confidence Interval
Number of bacterial taxa
Day 4
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00026
OG00130
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG00066.88461538(47.31497155 to 86.45425922)
OG00176.23333333(61.4245631 to 91.04210357)
OG00220.5(17.18168127 to 23.81831873)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.882449
Superiority
OG000
OG003
t-test, 2 sided
0.088558
Primary
Microbial Community Richness - (Day 5)
Swabs will be collected on the back at Day 5 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Posted
Mean
95% Confidence Interval
Number of bacterial taxa
Day 5
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00025
OG00127
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG00061.96(44.36091054 to 79.55908946)
OG00177.59259259(60.00060441 to 95.18458078)
OG00219.03225806(16.42738215 to 21.63713398)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.516068
Superiority
OG000
OG003
t-test, 2 sided
0.358412
Primary
Microbial Community Richness - (Day 6)
Swabs will be collected on the back at Day 6 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Posted
Mean
95% Confidence Interval
Number of bacterial taxa
Day 6
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00018
OG00127
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG00048.5(35.54549519 to 61.45450481)
OG00175.88888889(61.54822817 to 90.2295496)
OG00223.55172414(20.03657535 to 27.06687293)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.00526
Superiority
OG000
OG003
t-test, 2 sided
1
Primary
Microbial Community Richness - (Day 7)
Swabs will be collected on the back at Day 7 and analyzed to determine the total number of different bacteria Taxa (microorganismss) detected in the sample.
Posted
Mean
95% Confidence Interval
Number of bacterial taxa
Day 7
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00022
OG00133
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG00054.54545455(40.08770259 to 69.0032065)
OG00181.51515152(62.74620188 to 100.2841011)
OG00231(23.08861196 to 38.91138804)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.066788
Superiority
OG000
OG003
t-test, 2 sided
0.942653
Primary
Microbial Community Richness - (Day 14)
Swabs will be collected on the back at Day 14 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.
Posted
Mean
95% Confidence Interval
Number of bacterial taxa
Day 14
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00030
OG00127
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG00073.1(57.23395854 to 88.96604146)
OG00166.44444444(48.7698287 to 84.11906019)
OG00228.34375(24.26615289 to 32.42134711)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.943522
Superiority
OG000
OG003
t-test, 2 sided
0.002376
Primary
Microbial Community Diversity - Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Shannon Index.
Posted
Mean
95% Confidence Interval
Shannon Diversity Index
Baseline (Day 0)
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00029
OG00122
OG00228
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.702946961(1.212183074 to 2.193710849)
OG0010.938913363(0.465348751 to 1.412477975)
OG0021.470084856(1.011374271 to 1.928795441)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.193667
Superiority
OG000
OG003
t-test, 2 sided
0.526573
Primary
Microbial Community Diversity - Day 1
Swabs will be collected on the back at Day 1 for analysis based on the Shannon Index.
Posted
Mean
95% Confidence Interval
Shannon Diversity Index
Day 1
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00032
OG00129
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.703357647(1.261265404 to 2.145449891)
OG0011.45014401(1.047686471 to 1.852601549)
OG0020.786918525(0.546103958 to 1.027733092)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.92106
Superiority
OG000
OG003
t-test, 2 sided
0.976812
Primary
Microbial Community Diversity - Day 2
Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.
Posted
Mean
95% Confidence Interval
Shannon Diversity Index
Day 2
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00032
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.776794637(1.324060973 to 2.229528302)
OG0011.866171013(1.449444421 to 2.282897605)
OG0020.793586986(0.62136427 to 0.965809702)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.998949
Superiority
OG000
OG003
t-test, 2 sided
0.111084
Primary
Microbial Community Diversity - Day 3
Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.
Posted
Mean
95% Confidence Interval
Shannon Diversity Index
Day 3
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00029
OG00132
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.85115546(1.382317602 to 2.319993318)
OG0011.765408531(1.338653068 to 2.192163994)
OG0020.7122095(0.538547591 to 0.885871409)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.99916
Superiority
OG000
OG003
t-test, 2 sided
0.016246
Primary
Microbial Community Diversity - Day 4
Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.
Posted
Mean
95% Confidence Interval
Shannon Diversity Index
Day 4
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00026
OG00130
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.932633093(1.431535105 to 2.433731082)
OG0011.88044173(1.433470325 to 2.327413134)
OG0020.797557627(0.628526357 to 0.966588896)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.999952
Superiority
OG000
OG003
t-test, 2 sided
0.421347
Primary
Microbial Community Diversity - Day 5
Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.
Posted
Mean
95% Confidence Interval
Shannon Diversity Index
Day 5
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00025
OG00127
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.783329786(1.22306299 to 2.343596582)
OG0011.664197367(1.212563987 to 2.115830748)
OG0020.700642641(0.529568098 to 0.871717184)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.997406
Superiority
OG000
OG003
t-test, 2 sided
0.354187
Primary
Microbial Community Diversity - Day 6
Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.
Posted
Mean
95% Confidence Interval
Shannon Diversity Index
Day 6
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00018
OG00127
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.782776526(1.184618285 to 2.380934768)
OG0011.799754753(1.346147213 to 2.253362293)
OG0020.865721173(0.642359805 to 1.089082541)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
1
Superiority
OG000
OG003
t-test, 2 sided
0.317315
Primary
Microbial Community Diversity - Day 7
Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.
Posted
Mean
95% Confidence Interval
Shannon Diversity Index
Day 7
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00022
OG00133
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.637800497(1.118090334 to 2.15751066)
OG0011.765588383(1.340278816 to 2.190897951)
OG0020.848189016(0.629210776 to 1.067167257)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.996522
Superiority
OG000
OG003
t-test, 2 sided
0.875832
Primary
Microbial Community Diversity - Day 14
Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.
Posted
Mean
95% Confidence Interval
Shannon Diversity Index
Day 14
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00030
OG00127
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.992920174(1.528772641 to 2.457067706)
OG0011.729295419(1.273786002 to 2.184804836)
OG0020.826824832(0.642994336 to 1.010655328)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.862516
Superiority
OG000
OG003
t-test, 2 sided
0.00473
Primary
Microbial Community Evenness - Baseline (Day 0)
Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Pielou's Evenness Index.
Posted
Mean
95% Confidence Interval
Pielou's Evenness Index
Day 0
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00029
OG00122
OG00228
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.410155753(0.305407316 to 0.51490419)
OG0010.271955307(0.143543228 to 0.400367386)
OG0020.402950073(0.37196059 to 0.518890538)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.016628
Superiority
OG000
OG003
t-test, 2 sided
0.217862
Primary
Microbial Community Evenness - Day 1
Swabs will be collected on the back at Day 1 for analysis based on the Pielou's Evenness Index.
Posted
Mean
95% Confidence Interval
Pielou's Evenness Index
Day 1
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00032
OG00129
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.437132278(0.330359027 to 0.54390553)
OG0010.349459879(0.255994131 to 0.442925627)
OG0020.246062404(0.173290416 to 0.318834392)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.393119
Superiority
OG000
OG003
t-test, 2 sided
0.890335
Primary
Microbial Community Evenness - Day 2
Swabs will be collected on the back at Day 2 for analysis based on the Pielou's Evenness Index.
Posted
Mean
95% Confidence Interval
Pielou's Evenness Index
Day 2
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00032
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.42693493(0.32874755 to 0.52512231)
OG0010.415386732(0.332645201 to 0.498128264)
OG0020.263575452(0.212813889 to 0.314337015)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.999858
Superiority
OG000
OG003
t-test, 2 sided
0.215132
Primary
Microbial Community Evenness - Day 3
Swabs will be collected on the back at Day 3 for analysis based on the Pielou's Evenness Index.
Posted
Mean
95% Confidence Interval
Pielou's Evenness Index
Day 3
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00029
OG00132
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.455666826(0.348282864 to 0.563050789)
OG0010.405262792(0.310526103 to 0.49999948)
OG0020.234966957(0.183226948 to 0.286706967)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.91874
Superiority
OG000
OG003
t-test, 2 sided
0.013582
Primary
Microbial Community Evenness - Day 4
Swabs will be collected on the back at Day 4 for analysis based on the Pielou's Evenness Index.
Posted
Mean
95% Confidence Interval
Pielou's Evenness Index
Day 4
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00026
OG00130
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.451377803(0.350796707 to 0.5519589)
OG0010.422737764(0.328361231 to 0.517114298)
OG0020.269049335(0.216107994 to 0.321990676)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.99253
Superiority
OG000
OG003
t-test, 2 sided
0.795279
Primary
Microbial Community Evenness - Day 5
Swabs will be collected on the back at Day 5 for analysis based on the Pielou's Evenness Index.
Posted
Mean
95% Confidence Interval
Pielou's Evenness Index
Day 5
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00025
OG00127
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.418779366(0.300422474 to 0.537136258)
OG0010.377673266(0.28316356 to 0.472182971)
OG0020.235666776(0.181164664 to 0.290168889)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.968005
Superiority
OG000
OG003
t-test, 2 sided
0.526293
Primary
Microbial Community Evenness - Day 6
Swabs will be collected on the back at Day 6 for analysis based on the Pielou's Evenness Index.
Posted
Mean
95% Confidence Interval
Pielou's Evenness Index
Day 6
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00018
OG00127
OG00229
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.446298915(0.307295525 to 0.585302305)
OG0010.417003638(0.315872307 to 0.51813497)
OG0020.270297461(0.208318912 to 0.33227601)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.995862
Superiority
OG000
OG003
t-test, 2 sided
0.223341
Primary
Microbial Community Evenness - Day 7
Swabs will be collected on the back at Day 7 for analysis based on the Pielou's Evenness Index.
Posted
Mean
95% Confidence Interval
Pielou's Evenness Index
Day 7
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00022
OG00133
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.410567291(0.286544213 to 0.534590369)
OG0010.404030653(0.309872763 to 0.498188542)
OG0020.247507869(0.190648545 to 0.304367193)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.999997
Superiority
OG000
OG003
t-test, 2 sided
0.938793
Primary
Microbial Community Evenness - Day 14
Swabs will be collected on the back at Day 14 for analysis based on the Pielou's Evenness Index.
Posted
Mean
95% Confidence Interval
Pielou's Evenness Index
Day 14
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00030
OG00127
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.454253238(0.360645958 to 0.547860518)
OG0010.402829439(0.309226175 to 0.496432702)
OG0020.249502521(0.196421318 to 0.302583723)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.891244
Superiority
OG000
OG003
t-test, 2 sided
0.022659
Secondary
Skin Barrier Function -Baseline (Day 0)
The skin barrier function of the test sites will be evaluated at Baseline (Day 0) by Trans Epidermal Water Loss (TEWL).
Posted
Mean
Standard Deviation
g/m^2/hr
Day 0
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00035
OG00135
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.82± 6.725
OG00196.94± 11.682
OG002101.08± 9.992
OG003
Secondary
Skin Barrier Function - Day 1
The skin barrier function of the test sites will be evaluated at Day 1 by Trans Epidermal Water Loss (TEWL).
Posted
Mean
Standard Deviation
g/m^2/hr
Day 1
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00034
OG00134
OG00234
OG003
Title
Denominators
Categories
Title
Measurements
OG00013.05± 13.414
OG00195.68± 16.393
OG00292.40± 10.886
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1
ANCOVA
0.009
Mean Difference (Net)
-7.50
Standard Error of the Mean
2.851
2-Sided
95
-13.1279
-1.8688
Superiority
OG001
OG003
Secondary
Skin Barrier Function - Day 2
The skin barrier function of the test sites will be evaluated at Day 2 by Trans Epidermal Water Loss (TEWL).
Posted
Mean
Standard Deviation
g/m^2/hr
Day 2
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00033
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG00010.97± 7.527
OG00180.26± 22.229
OG00273.10± 16.557
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2
ANCOVA
<0.001
Mean Difference (Net)
-11.37
Standard Error of the Mean
3.038
2-Sided
95
-17.3738
-5.3723
Superiority
OG001
OG003
Secondary
Skin Barrier Function - Day 3
The skin barrier function of the test sites will be evaluated at Day 3 by Trans Epidermal Water Loss (TEWL).
Posted
Mean
Standard Deviation
g/m^2/hr
Day 3
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00033
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG00015.46± 18.864
OG00177.40± 24.567
OG00250.41± 23.291
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3
ANCOVA
<0.001
Mean Difference (Net)
-31.83
Standard Error of the Mean
4.847
2-Sided
95
-41.3967
-22.2538
Superiority
OG001
OG003
Secondary
Skin Barrier Function - Day 4
The skin barrier function of the test sites will be evaluated at Day 4 by Trans Epidermal Water Loss (TEWL).
Posted
Mean
Standard Deviation
g/m^2/hr
Day 4
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00034
OG00134
OG00234
OG003
Title
Denominators
Categories
Title
Measurements
OG00016.70± 19.227
OG00172.49± 25.078
OG00236.32± 35.19
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4
ANCOVA
<0.001
Mean Difference (Net)
-40.39
Standard Error of the Mean
5.390
2-Sided
95
-51.0324
-29.7496
Superiority
OG001
OG003
Secondary
Skin Barrier Function - Day 5
The skin barrier function of the test sites will be evaluated at Day 5 by Trans Epidermal Water Loss (TEWL).
Posted
Mean
Standard Deviation
g/m^2/hr
Day 5
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00033
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG00012.77± 16.829
OG00158.87± 25.914
OG00230.80± 21.510
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5
ANCOVA
<0.001
Mean Difference (Net)
-32.90
Standard Error of the Mean
5.276
2-Sided
95
-43.3249
-22.4838
Superiority
OG001
OG003
Secondary
Skin Barrier Function - Day 6
The skin barrier function of the test sites will be evaluated at Day 6 by Trans Epidermal Water Loss (TEWL).
Posted
Mean
Standard Deviation
g/m^2/hr
Day 6
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00032
OG00132
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.94± 8.699
OG00147.34± 20.318
OG00221.28± 8.524
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6
ANCOVA
<0.001
Mean Difference (Net)
-30.90
Standard Error of the Mean
4.371
2-Sided
95
-39.5325
-22.2650
Superiority
OG001
OG003
Secondary
Skin Barrier Function - Day 7
The skin barrier function of the test sites will be evaluated at Day 7 by Trans Epidermal Water Loss (TEWL).
Posted
Mean
Standard Deviation
g/m^2/hr
Day 7
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00033
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.80± 4.252
OG00130.36± 16.556
OG00221.23± 12.719
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7
ANCOVA
<0.001
Mean Difference (Net)
-13.95
Standard Error of the Mean
3.754
2-Sided
95
-21.3680
-6.5419
Superiority
OG001
OG003
Secondary
Skin Barrier Function - Day 14
The skin barrier function of the test sites will be evaluated at Day 14 by Trans Epidermal Water Loss (TEWL).
Posted
Mean
Standard Deviation
g/m^2/hr
Day 14
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00033
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG00010.32± 14.697
OG00114.58± 13.016
OG00216.66± 9.356
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14
ANCOVA
0.397
Mean Difference (Net)
-2.76
Standard Error of the Mean
3.244
2-Sided
95
-9.1631
3.6504
Superiority
OG001
OG003
Secondary
Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Posted
Mean
Standard Deviation
Arbitrary Unit
Day 0
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00027
OG00130
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.82± 0.143
OG0010.97± 0.189
OG0020.96± 0.143
OG003
Secondary
Redness: Wound Area Oxyhemoglobin Level - Day 1
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Posted
Mean
Standard Deviation
Arbitrary Unit
Day 1
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00025
OG00126
OG00226
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.83± 0.127
OG0011.20± 0.170
OG0021.15± 0.181
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1
ANCOVA
0.348
Mean Difference (Net)
-0.04
Standard Error of the Mean
0.044
2-Sided
95
-0.1290
0.0458
Superiority
OG001
OG003
Secondary
Redness: Wound Area Oxyhemoglobin Level - Day 2
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Posted
Mean
Standard Deviation
Arbitrary Unit
Day 2
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00026
OG00127
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.85± 0.100
OG0011.21± 0.166
OG0021.16± 0.181
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2
ANCOVA
0.516
Mean Difference (Net)
-0.03
Standard Error of the Mean
0.052
2-Sided
95
-0.1360
0.0687
Superiority
OG001
OG003
Secondary
Redness: Wound Area Oxyhemoglobin Level - Day 3
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Posted
Mean
Standard Deviation
Arbitrary Unit
Day 3
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00014
OG00117
OG00216
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.81± 0.156
OG0011.16± 0.211
OG0021.08± 0.121
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3
ANCOVA
0.292
Mean Difference (Net)
-0.07
Standard Error of the Mean
0.062
2-Sided
95
-0.1896
0.0579
Superiority
OG001
OG003
Secondary
Redness: Wound Area Oxyhemoglobin Level - Day 4
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Posted
Mean
Standard Deviation
Arbitrary Unit
Day 4
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00031
OG00133
OG00234
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.81± 0.138
OG0011.20± 0.166
OG0020.99± 0.217
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4
ANCOVA
0.001
Mean Difference (Net)
-0.21
Standard Error of the Mean
0.060
2-Sided
95
-0.3265
-0.0895
Superiority
OG001
OG003
Secondary
Redness: Wound Area Oxyhemoglobin Level - Day 5
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Posted
Mean
Standard Deviation
Arbitrary Unit
Day 5
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00024
OG00124
OG00223
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.81± 0.159
OG0011.14± 0.208
OG0020.90± 0.146
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5
ANCOVA
<0.001
Mean Difference (Net)
-0.23
Standard Error of the Mean
0.051
2-Sided
95
-0.3331
-0.1305
Superiority
OG001
OG003
Secondary
Redness: Wound Area Oxyhemoglobin Level - Day 6
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Posted
Mean
Standard Deviation
Arbitrary Unit
Day 6
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00030
OG00130
OG00228
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.80± 0.124
OG0011.20± 0.230
OG0020.88± 0.146
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6
ANCOVA
<0.001
Mean Difference (Net)
-0.30
Standard Error of the Mean
0.050
2-Sided
95
-0.4019
-0.2044
Superiority
OG001
OG003
Secondary
Redness: Wound Area Oxyhemoglobin Level - Day 7
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Posted
Mean
Standard Deviation
Arbitrary Unit
Day 7
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00032
OG00133
OG00233
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.78± 0.111
OG0011.02± 0.191
OG0020.88± 0.164
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7
ANCOVA
0.006
Mean Difference (Net)
-0.13
Standard Error of the Mean
0.047
2-Sided
95
-0.2254
-0.0384
Superiority
OG001
OG003
Secondary
Redness: Wound Area Oxyhemoglobin Level - Day 14
Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.
Posted
Mean
Standard Deviation
Arbitrary Unit
Day 14
ID
Title
Description
OG000
Intact Uncovered Skin
Intact Uncovered Skin
OG001
Wounded Uncovered Skin
Wounded Uncovered Skin
OG002
Product #1
Product #1
OG003
Product #2
Product #2
OG004
Product #3
Product #3
OG005
Product #4
Product #4
Units
Counts
Participants
OG00029
OG00130
OG00228
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.79± 0.120
OG0010.90± 0.147
OG0020.89± 0.146
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14
ANCOVA
0.937
Mean Difference (Net)
-0.00
Standard Error of the Mean
0.040
2-Sided
95
-0.0818
0.0755
Superiority
OG001
OG003
35
0
35
0
35
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
32
OG00419
OG00524
OG003
53.5
(37.61649637 to 69.38350363)
OG00442.47368421(27.00391618 to 57.94345224)
OG00528.83333333(20.99591479 to 36.67075187)
Superiority
OG000
OG004
t-test, 2 sided
0.870459
Superiority
OG000
OG002
t-test, 2 sided
0.004963
Superiority
OG000
OG005
t-test, 2 sided
0.071935
Superiority
OG001
OG003
t-test, 2 sided
0.988995
Superiority
OG001
OG004
t-test, 2 sided
0.545378
Superiority
OG001
OG002
t-test, 2 sided
0.000649
Superiority
OG001
OG005
t-test, 2 sided
0.014600
Superiority
OG003
OG004
t-test, 2 sided
0.854566
Superiority
OG002
OG003
t-test, 2 sided
0.004322
Superiority
OG003
OG005
t-test, 2 sided
0.0651
Superiority
OG002
OG004
t-test, 2 sided
0.300536
Superiority
OG004
OG005
t-test, 2 sided
0.753883
Superiority
OG002
OG005
t-test, 2 sided
0.97621
Superiority
32
OG00427
OG00532
OG00336.65625(30.26643624 to 43.04606376)
OG00433.7037037(22.14710131 to 45.2603061)
OG00530.40625(23.74762413 to 37.06487587)
Superiority
OG000
OG004
t-test, 2 sided
0.049247
Superiority
OG000
OG002
t-test, 2 sided
0.000126
Superiority
OG000
OG005
t-test, 2 sided
0.010829
Superiority
OG001
OG003
t-test, 2 sided
<0.001
Superiority
OG001
OG004
t-test, 2 sided
<0.001
Superiority
OG001
OG002
t-test, 2 sided
<0.001
Superiority
OG001
OG005
t-test, 2 sided
<0.001
Superiority
OG003
OG004
t-test, 2 sided
0.999533
Superiority
OG002
OG003
t-test, 2 sided
0.4205363
Superiority
OG003
OG005
t-test, 2 sided
0.9802252
Superiority
OG002
OG004
t-test, 2 sided
0.6845362
Superiority
OG004
OG005
t-test, 2 sided
0.9992002
Superiority
OG002
OG005
t-test, 2 sided
0.8562779
Superiority
27
OG00425
OG00532
OG00338.25925926(29.78367344 to 46.73484508)
OG00437.88(23.44927006 to 52.31072994)
OG00530.28125(23.87137083 to 36.69112917)
Superiority
OG000
OG004
t-test, 2 sided
0.290551
Superiority
OG000
OG002
t-test, 2 sided
0.0000247
Superiority
OG000
OG005
t-test, 2 sided
0.0133001
Superiority
OG001
OG003
t-test, 2 sided
0.0000167
Superiority
OG001
OG004
t-test, 2 sided
0.0000212
Superiority
OG001
OG002
t-test, 2 sided
<0.001
Superiority
OG001
OG005
t-test, 2 sided
<0.001
Superiority
OG003
OG004
t-test, 2 sided
0.99999995
Superiority
OG002
OG003
t-test, 2 sided
0.0792013
Superiority
OG003
OG005
t-test, 2 sided
0.870163
Superiority
OG002
OG004
t-test, 2 sided
0.103828
Superiority
OG004
OG005
t-test, 2 sided
0.900265
Superiority
OG002
OG005
t-test, 2 sided
0.570015
Superiority
31
OG00428
OG00532
OG00344.35483871(33.45042213 to 55.25925529)
OG00443.53571429(29.33570468 to 57.73572389)
OG00525.59375(20.71187082 to 30.47562918)
Superiority
OG000
OG004
t-test, 2 sided
0.081846
Superiority
OG000
OG002
t-test, 2 sided
<0.001
Superiority
OG000
OG005
t-test, 2 sided
0.0000303
Superiority
OG001
OG003
t-test, 2 sided
0.001817
Superiority
OG001
OG004
t-test, 2 sided
0.001825
Superiority
OG001
OG002
t-test, 2 sided
<0.001
Superiority
OG001
OG005
t-test, 2 sided
<0.001
Superiority
OG003
OG004
t-test, 2 sided
0.999999
Superiority
OG002
OG003
t-test, 2 sided
0.038836
Superiority
OG003
OG005
t-test, 2 sided
0.184508
Superiority
OG002
OG004
t-test, 2 sided
0.062829
Superiority
OG004
OG005
t-test, 2 sided
0.253458
Superiority
OG002
OG005
t-test, 2 sided
0.987798
Superiority
27
OG00421
OG00531
OG00344.03703704(29.83167678 to 58.2423973)
OG00450.33333333(32.41789542 to 68.24877125)
OG00525.80645161(21.1508763 to 30.46202693)
Superiority
OG000
OG004
t-test, 2 sided
0.834145
Superiority
OG000
OG002
t-test, 2 sided
0.000035
Superiority
OG000
OG005
t-test, 2 sided
0.000843
Superiority
OG001
OG003
t-test, 2 sided
0.002997
Superiority
OG001
OG004
t-test, 2 sided
0.051717
Superiority
OG001
OG002
t-test, 2 sided
<0.001
Superiority
OG001
OG005
t-test, 2 sided
<0.001
Superiority
OG003
OG004
t-test, 2 sided
0.985602
Superiority
OG002
OG003
t-test, 2 sided
0.046422
Superiority
OG003
OG005
t-test, 2 sided
0.28061
Superiority
OG002
OG004
t-test, 2 sided
0.011015
Superiority
OG004
OG005
t-test, 2 sided
0.089156
Superiority
OG002
OG005
t-test, 2 sided
0.963882
Superiority
27
OG00419
OG00530
OG00348.81481481(37.40801959 to 60.22161004)
OG00440.26315789(26.53167948 to 53.99463631)
OG00525.63333333(21.01769583 to 30.24897084)
Superiority
OG000
OG004
t-test, 2 sided
0.914409
Superiority
OG000
OG002
t-test, 2 sided
0.013004
Superiority
OG000
OG005
t-test, 2 sided
0.028517
Superiority
OG001
OG003
t-test, 2 sided
0.001356
Superiority
OG001
OG004
t-test, 2 sided
0.000059
Superiority
OG001
OG002
t-test, 2 sided
<0.001
Superiority
OG001
OG005
t-test, 2 sided
<0.001
Superiority
OG003
OG004
t-test, 2 sided
0.859272
Superiority
OG002
OG003
t-test, 2 sided
0.002821
Superiority
OG003
OG005
t-test, 2 sided
0.007492
Superiority
OG002
OG004
t-test, 2 sided
0.208803
Superiority
OG004
OG005
t-test, 2 sided
0.341884
Superiority
OG002
OG005
t-test, 2 sided
0.999531
Superiority
25
OG00421
OG00533
OG003
45.12
(28.23285287 to 62.00714713)
OG00443.04761905(27.89745068 to 58.19778741)
OG00530.57575758(24.32822886 to 36.82328629)
Superiority
OG000
OG004
t-test, 2 sided
0.893545
Superiority
OG000
OG002
t-test, 2 sided
0.165225
Superiority
OG000
OG005
t-test, 2 sided
0.140475
Superiority
OG001
OG003
t-test, 2 sided
0.002026
Superiority
OG001
OG004
t-test, 2 sided
0.001916
Superiority
OG001
OG002
t-test, 2 sided
<0.001
Superiority
OG001
OG005
t-test, 2 sided
<0.001
Superiority
OG003
OG004
t-test, 2 sided
0.999957
Superiority
OG002
OG003
t-test, 2 sided
0.672573
Superiority
OG003
OG005
t-test, 2 sided
0.630145
Superiority
OG002
OG004
t-test, 2 sided
0.832757
Superiority
OG004
OG005
t-test, 1 sided
0.803277
Superiority
OG002
OG005
t-test, 2 sided
1
Superiority
32
OG00425
OG00533
OG003
46.21875
(39.38246899 to 53.05503101)
OG00432.32(25.7083049 to 38.9316951)
OG00530.45454545(25.6128987 to 35.29619221)
Superiority
OG000
OG004
t-test, 2 sided
<0.001
Superiority
OG000
OG002
t-test, 2 sided
<0.001
Superiority
OG000
OG005
t-test, 2 sided
<0.001
Superiority
OG001
OG003
t-test, 2 sided
0.061015
Superiority
OG001
OG004
t-test, 2 sided
0.000211
Superiority
OG001
OG002
t-test, 2 sided
<0.001
Superiority
OG001
OG005
t-test, 2 sided
<0.001
Superiority
OG003
OG004
t-test, 2 sided
0.412626
Superiority
OG002
OG003
t-test, 2 sided
0.104388
Superiority
OG003
OG005
t-test, 2 sided
0.197791
Superiority
OG002
OG004
t-test, 2 sided
0.994413
Superiority
OG004
OG005
t-test, 2 sided
0.999851
Superiority
OG002
OG005
t-test, 2 sided
0.999621
Superiority
27
OG00423
OG00527
OG0031.16250018(0.709007612 to 1.615992753)
OG0041.355575793(0.832569386 to 1.8785822)
OG0051.278886018(0.840487425 to 1.717284611)
Superiority
OG000
OG004
t-test, 2 sided
0.898749
Superiority
OG000
OG002
t-test, 2 sided
0.975044
Superiority
OG000
OG005
t-test, 2 sided
0.760706
Superiority
OG001
OG003
t-test, 2 sided
0.985237
Superiority
OG001
OG004
t-test, 2 sided
0.837995
Superiority
OG001
OG002
t-test, 2 sided
0.592697
Superiority
OG001
OG005
t-test, 2 sided
0.912495
Superiority
OG003
OG004
t-test, 2 sided
0.99245
Superiority
OG002
OG003
t-test, 2 sided
0.925553
Superiority
OG003
OG005
t-test, 2 sided
0.999171
Superiority
OG002
OG004
t-test, 2 sided
0.999324
Superiority
OG004
OG005
t-test, 2 sided
0.999913
Superiority
OG002
OG005
t-test, 2 sided
0.990516
Superiority
32
OG00419
OG00524
OG0031.518890457(1.116626746 to 1.921154169)
OG0041.060560749(0.544639084 to 1.576482413)
OG0050.900390717(0.622715277 to 1.178066157)
Superiority
OG000
OG004
t-test, 2 sided
0.233992
Superiority
OG000
OG002
t-test, 2 sided
0.007591
Superiority
OG000
OG005
t-test, 2 sided
0.038958
Superiority
OG001
OG003
t-test, 2 sided
0.99809
Superiority
OG001
OG004
t-test, 2 sided
0.773028
Superiority
OG001
OG002
t-test, 2 sided
0.135805
Superiority
OG001
OG005
t-test, 2 sided
0.350556
Superiority
OG003
OG004
t-test, 2 sided
0.61046
Superiority
OG002
OG003
t-test, 2 sided
0.062163
Superiority
OG003
OG005
t-test, 2 sided
0.203418
Superiority
OG002
OG004
t-test, 2 sided
0.942304
Superiority
OG004
OG005
t-test, 2 sided
0.995238
Superiority
OG002
OG005
t-test, 2 sided
0.99858
Superiority
32
OG00427
OG00532
OG0031.169519236(0.888383719 to 1.450654753)
OG0041.327096148(0.903682194 to 1.750510103)
OG0050.941432164(0.692964696 to 1.189899633)
Superiority
OG000
OG004
t-test, 2 sided
0.456846
Superiority
OG000
OG002
t-test, 2 sided
0.00062
Superiority
OG000
OG005
t-test, 2 sided
0.006871
Superiority
OG001
OG003
t-test, 2 sided
0.039407
Superiority
OG001
OG004
t-test, 2 sided
0.245375
Superiority
OG001
OG002
t-test, 2 sided
0.000113
Superiority
OG001
OG005
t-test, 2 sided
0.001612
Superiority
OG003
OG004
t-test, 2 sided
0.988067
Superiority
OG002
OG003
t-test, 2 sided
0.599171
Superiority
OG003
OG005
t-test, 2 sided
0.928722
Superiority
OG002
OG004
t-test, 2 sided
0.256079
Superiority
OG004
OG005
t-test, 2 sided
0.626498
Superiority
OG002
OG005
t-test, 2 sided
0.988693
Superiority
27
OG00425
OG00532
OG0031.046670711(0.736643325 to 1.356698098)
OG0041.322070974(0.943427192 to 1.700714756)
OG0051.071628134(0.813088017 to 1.330168251)
Superiority
OG000
OG004
t-test, 2 sided
0.289112
Superiority
OG000
OG002
t-test, 2 sided
0.000038
Superiority
OG000
OG005
t-test, 2 sided
0.014558
Superiority
OG001
OG003
t-test, 2 sided
0.03731
Superiority
OG001
OG004
t-test, 2 sided
0.465745
Superiority
OG001
OG002
t-test, 2 sided
0.000112
Superiority
OG001
OG005
t-test, 2 sided
0.034575
Superiority
OG003
OG004
t-test, 2 sided
0.889597
Superiority
OG002
OG003
t-test, 2 sided
0.726932
Superiority
OG003
OG005
t-test, 2 sided
0.999998
Superiority
OG002
OG004
t-test, 2 sided
0.130235
Superiority
OG004
OG005
t-test, 2 sided
0.910989
Superiority
OG002
OG005
t-test, 2 sided
0.616933
Superiority
31
OG00428
OG00532
OG0031.453888326(1.117071932 to 1.790704721)
OG0041.513528952(1.052864028 to 1.974193877)
OG0050.76492761(0.567335326 to 0.962519895)
Superiority
OG000
OG004
t-test, 2 sided
0.598141
Superiority
OG000
OG002
t-test, 2 sided
0.000197
Superiority
OG000
OG005
t-test, 2 sided
0.000115
Superiority
OG001
OG003
t-test, 2 sided
0.511155
Superiority
OG001
OG004
t-test, 2 sided
0.693868
Superiority
OG001
OG002
t-test, 2 sided
0.000232
Superiority
OG001
OG005
t-test, 2 sided
0.000133
Superiority
OG003
OG004
t-test, 2 sided
0.999894
Superiority
OG002
OG003
t-test, 2 sided
0.078046
Superiority
OG003
OG005
t-test, 2 sided
0.054975
Superiority
OG002
OG004
t-test, 2 sided
0.050132
Superiority
OG004
OG005
t-test, 2 sided
0.034793
Superiority
OG002
OG005
t-test, 2 sided
0.999993
Superiority
27
OG00421
OG00531
OG0031.267584901(0.901217742 to 1.633952061)
OG0041.480613855(0.994345968 to 1.966881743)
OG0050.68710958(0.515014462 to 0.859204698)
Superiority
OG000
OG004
t-test, 2 sided
0.883222
Superiority
OG000
OG002
t-test, 2 sided
0.000412
Superiority
OG000
OG005
t-test, 2 sided
0.000332
Superiority
OG001
OG003
t-test, 2 sided
0.626878
Superiority
OG001
OG004
t-test, 2 sided
0.984465
Superiority
OG001
OG002
t-test, 2 sided
0.001845
Superiority
OG001
OG005
t-test, 2 sided
0.001507
Superiority
OG003
OG004
t-test, 2 sided
0.970029
Superiority
OG002
OG003
t-test, 2 sided
0.19886
Superiority
OG003
OG005
t-test, 2 sided
0.177549
Superiority
OG002
OG004
t-test, 2 sided
0.041698
Superiority
OG004
OG005
t-test, 2 sided
0.036131
Superiority
OG002
OG005
t-test, 2 sided
1
Superiority
27
OG00419
OG00530
OG0031.223240388(0.927644983 to 1.518835794)
OG0041.425318411(0.881697663 to 1.968939159)
OG0050.698409234(0.484505139 to 0.912313329)
Superiority
OG000
OG004
t-test, 2 sided
0.829352
Superiority
OG000
OG002
t-test, 2 sided
0.010561
Superiority
OG000
OG005
t-test, 2 sided
0.001099
Superiority
OG001
OG003
t-test, 2 sided
0.175148
Superiority
OG001
OG004
t-test, 2 sided
0.728796
Superiority
OG001
OG002
t-test, 2 sided
0.001992
Superiority
OG001
OG005
t-test, 2 sided
0.000113
Superiority
OG003
OG004
t-test, 2 sided
0.974567
Superiority
OG002
OG003
t-test, 2 sided
0.668933
Superiority
OG003
OG005
t-test, 2 sided
0.239446
Superiority
OG002
OG004
t-test, 2 sided
0.283848
Superiority
OG004
OG005
t-test, 2 sided
0.06829
Superiority
OG002
OG005
t-test, 2 sided
0.979516
Superiority
25
OG00421
OG00533
OG0031.328769036(0.915319287 to 1.742218786)
OG0041.367835908(0.901653933 to 1.834017883)
OG0050.791935871(0.565396501 to 1.018475241)
Superiority
OG000
OG004
t-test, 2 sided
0.938
Superiority
OG000
OG002
t-test, 2 sided
0.038527
Superiority
OG000
OG005
t-test, 2 sided
0.018334
Superiority
OG001
OG003
t-test, 2 sided
0.512209
Superiority
OG001
OG004
t-test, 2 sided
0.665529
Superiority
OG001
OG002
t-test, 2 sided
0.002257
Superiority
OG001
OG005
t-test, 2 sided
0.000728
Superiority
OG003
OG004
t-test, 2 sided
0.999993
Superiority
OG002
OG003
t-test, 2 sided
0.417914
Superiority
OG003
OG005
t-test, 2 sided
0.277469
Superiority
OG002
OG004
t-test, 2 sided
0.385419
Superiority
OG004
OG005
t-test, 2 sided
0.257647
Superiority
OG002
OG005
t-test, 2 sided
0.999897
Superiority
32
OG00425
OG00533
OG0031.188271444(0.950876818 to 1.42566607)
OG0041.362870394(0.978315938 to 1.747424849)
OG0050.729090928(0.540015069 to 0.918166787)
Superiority
OG000
OG004
t-test, 2 sided
0.085238
Superiority
OG000
OG002
t-test, 2 sided
<0.001
Superiority
OG000
OG005
t-test, 2 sided
<0.001
Superiority
OG001
OG003
t-test, 2 sided
0.168409
Superiority
OG001
OG004
t-test, 2 sided
0.652654
Superiority
OG001
OG002
t-test, 2 sided
0.001436
Superiority
OG001
OG005
t-test, 2 sided
0.000235
Superiority
OG003
OG004
t-test, 2 sided
0.974842
Superiority
OG002
OG003
t-test, 2 sided
0.557877
Superiority
OG003
OG005
t-test, 2 sided
0.277244
Superiority
OG002
OG004
t-test, 2 sided
0.195527
Superiority
OG004
OG005
t-test, 2 sided
0.070843
Superiority
OG002
OG005
t-test, 2 sided
0.997565
Superiority
27
OG00423
OG00527
OG0030.320061269(0.201925423 to 0.438197114)
OG0040.358334602(0.228095257 to 0.488573947)
OG0050.325047059(0.217282735 to 0.432811384)
Superiority
OG000
OG004
t-test, 2 sided
0.812915
Superiority
OG000
OG002
t-test, 2 sided
0.999971
Superiority
OG000
OG005
t-test, 2 sided
0.275557
Superiority
OG001
OG003
t-test, 2 sided
0.870124
Superiority
OG001
OG004
t-test, 2 sided
0.380144
Superiority
OG001
OG002
t-test, 2 sided
0.029518
Superiority
OG001
OG005
t-test, 2 sided
0.815476
Superiority
OG003
OG004
t-test, 2 sided
0.944307
Superiority
OG002
OG003
t-test, 2 sided
0.313389
Superiority
OG003
OG005
t-test, 2 sided
0.999996
Superiority
OG002
OG004
t-test, 2 sided
0.894272
Superiority
OG004
OG005
t-test, 2 sided
0.969093
Superiority
OG002
OG005
t-test, 2 sided
0.383434
Superiority
32
OG00419
OG00524
OG0030.389333736(0.294031092 to 0.484636381)
OG0040.273028286(0.154944552 to 0.391112019)
OG0050.265726584(0.192716814 to 0.338736354)
Superiority
OG000
OG004
t-test, 2 sided
0.021978
Superiority
OG000
OG002
t-test, 2 sided
0.000983
Superiority
OG000
OG005
t-test, 2 sided
0.006615
Superiority
OG001
OG003
t-test, 2 sided
0.951883
Superiority
OG001
OG004
t-test, 2 sided
0.692455
Superiority
OG001
OG002
t-test, 2 sided
0.257254
Superiority
OG001
OG005
t-test, 2 sided
0.530181
Superiority
OG003
OG004
t-test, 2 sided
0.219274
Superiority
OG002
OG003
t-test, 2 sided
0.029675
Superiority
OG003
OG005
t-test, 2 sided
0.111454
Superiority
OG002
OG004
t-test, 2 sided
0.995849
Superiority
OG004
OG005
t-test, 2 sided
0.999994
Superiority
OG002
OG005
t-test, 2 sided
0.998744
Superiority
32
OG00427
OG00532
OG0030.322568391(0.249971799 to 0.395164982)
OG0040.386309873(0.276870199 to 0.495749548)
OG0050.277342605(0.212258941 to 0.342426269)
Superiority
OG000
OG004
t-test, 2 sided
0.958812
Superiority
OG000
OG002
t-test, 2 sided
0.00622
Superiority
OG000
OG005
t-test, 2 sided
0.017733
Superiority
OG001
OG003
t-test, 2 sided
0.330576
Superiority
OG001
OG004
t-test, 2 sided
0.990334
Superiority
OG001
OG002
t-test, 2 sided
0.013025
Superiority
OG001
OG005
t-test, 2 sided
0.034707
Superiority
OG003
OG004
t-test, 2 sided
0.771698
Superiority
OG002
OG003
t-test, 2 sided
0.790117
Superiority
OG003
OG005
t-test, 2 sided
0.923224
Superiority
OG002
OG004
t-test, 2 sided
0.112245
Superiority
OG004
OG005
t-test, 2 sided
0.216229
Superiority
OG002
OG005
t-test, 2 sided
0.999663
Superiority
27
OG00425
OG00532
OG0030.279414327(0.204200672 to 0.354627983)
OG0040.363143499(0.268134344 to 0.458152655)
OG0050.312661752(0.250785086 to 0.374538417)
Superiority
OG000
OG004
t-test, 2 sided
0.523284
Superiority
OG000
OG002
t-test, 2 sided
0.000315
Superiority
OG000
OG005
t-test, 2 sided
0.059485
Superiority
OG001
OG003
t-test, 2 sided
0.15037
Superiority
OG001
OG004
t-test, 2 sided
0.967277
Superiority
OG001
OG002
t-test, 2 sided
0.008729
Superiority
OG001
OG005
t-test, 2 sided
0.421603
Superiority
OG003
OG004
t-test, 2 sided
0.647267
Superiority
OG002
OG003
t-test, 2 sided
0.953645
Superiority
OG003
OG005
t-test, 2 sided
0.987387
Superiority
OG002
OG004
t-test, 2 sided
0.147361
Superiority
OG004
OG005
t-test, 2 sided
0.930371
Superiority
OG002
OG005
t-test, 2 sided
0.6094
Superiority
31
OG00428
OG00532
OG0030.38804873(0.312100017 to 0.463997444)
OG0040.392633921(0.288519448 to 0.496748395)
OG0050.231556861(0.177760893 to 0.285352829)
Superiority
OG000
OG004
t-test, 2 sided
0.855067
Superiority
OG000
OG002
t-test, 2 sided
0.003915
Superiority
OG000
OG005
t-test, 2 sided
0.000221
Superiority
OG001
OG003
t-test, 2 sided
0.97816
Superiority
OG001
OG004
t-test, 2 sided
0.98972
Superiority
OG001
OG002
t-test, 2 sided
0.01764
Superiority
OG001
OG005
t-test, 2 sided
0.001185
Superiority
OG003
OG004
t-test, 2 sided
0.999999
Superiority
OG002
OG003
t-test, 2 sided
0.119961
Superiority
OG003
OG005
t-test, 2 sided
0.013468
Superiority
OG002
OG004
t-test, 2 sided
0.112192
Superiority
OG004
OG005
t-test, 2 sided
0.013135
Superiority
OG002
OG005
t-test, 2 sided
0.965966
Superiority
27
OG00421
OG00531
OG0030.330181203(0.249683185 to 0.410679222)
OG0040.388971323(0.268970894 to 0.508971751)
OG0050.212340111(0.163649748 to 0.261030475)
Superiority
OG000
OG004
t-test, 2 sided
0.994384
Superiority
OG000
OG002
t-test, 2 sided
0.004967
Superiority
OG000
OG005
t-test, 2 sided
0.000948
Superiority
OG001
OG003
t-test, 2 sided
0.936394
Superiority
OG001
OG004
t-test, 2 sided
0.999945
Superiority
OG001
OG002
t-test, 2 sided
0.050032
Superiority
OG001
OG005
t-test, 2 sided
0.01256
Superiority
OG003
OG004
t-test, 2 sided
0.886978
Superiority
OG002
OG003
t-test, 2 sided
0.391295
Superiority
OG003
OG005
t-test, 2 sided
0.163678
Superiority
OG002
OG004
t-test, 2 sided
0.047937
Superiority
OG004
OG005
t-test, 2 sided
0.013231
Superiority
OG002
OG005
t-test, 2 sided
0.996358
Superiority
27
OG00419
OG00530
OG0030.31595456(0.242353894 to 0.389555227)
OG0040.370960196(0.242456263 to 0.499464128)
OG0050.213078749(0.150385636 to 0.275771862)
Superiority
OG000
OG004
t-test, 2 sided
0.834338
Superiority
OG000
OG002
t-test, 2 sided
0.030267
Superiority
OG000
OG005
t-test, 2 sided
0.00104
Superiority
OG001
OG003
t-test, 2 sided
0.377217
Superiority
OG001
OG004
t-test, 2 sided
0.965547
Superiority
OG001
OG002
t-test, 2 sided
0.052284
Superiority
OG001
OG005
t-test, 2 sided
0.001348
Superiority
OG003
OG004
t-test, 2 sided
0.927936
Superiority
OG002
OG003
t-test, 2 sided
0.946487
Superiority
OG003
OG005
t-test, 2 sided
0.327918
Superiority
OG002
OG004
t-test, 2 sided
0.475038
Superiority
OG004
OG005
t-test, 2 sided
0.060057
Superiority
OG002
OG005
t-test, 2 sided
0.857177
Superiority
25
OG00421
OG00533
OG0030.354717133(0.259034665 to 0.450399602)
OG0040.359914043(0.242240002 to 0.477588085)
OG0050.230659131(0.174438405 to 0.286879856)
Superiority
OG000
OG004
t-test, 2 sided
0.965993
Superiority
OG000
OG002
t-test, 2 sided
0.057803
Superiority
OG000
OG005
t-test, 2 sided
0.022816
Superiority
OG001
OG003
t-test, 2 sided
0.945179
Superiority
OG001
OG004
t-test, 2 sided
0.972522
Superiority
OG001
OG002
t-test, 2 sided
0.033704
Superiority
OG001
OG005
t-test, 2 sided
0.010747
Superiority
OG003
OG004
t-test, 2 sided
0.999999
Superiority
OG002
OG003
t-test, 2 sided
0.385474
Superiority
OG003
OG005
t-test, 2 sided
0.213798
Superiority
OG002
OG004
t-test, 2 sided
0.388682
Superiority
OG004
OG005
t-test, 2 sided
0.22386
Superiority
OG002
OG005
t-test, 2 sided
0.999494
Superiority
32
OG00425
OG00533
OG0030.308795465(0.25494207 to 0.362648861)
OG0040.383110745(0.283994153 to 0.482227337)
OG0050.210741952(0.159426533 to 0.262057372)
Superiority
OG000
OG004
t-test, 2 sided
0.693615
Superiority
OG000
OG002
t-test, 2 sided
0.000237
Superiority
OG000
OG005
t-test, 2 sided
0.000005
Superiority
OG001
OG003
t-test, 2 sided
0.352008
Superiority
OG001
OG004
t-test, 2 sided
0.998761
Superiority
OG001
OG002
t-test, 2 sided
0.017832
Superiority
OG001
OG005
t-test, 2 sided
0.000974
Superiority
OG003
OG004
t-test, 2 sided
0.638238
Superiority
OG002
OG003
t-test, 2 sided
0.777423
Superiority
OG003
OG005
t-test, 2 sided
0.249909
Superiority
OG002
OG004
t-test, 2 sided
0.068196
Superiority
OG004
OG005
t-test, 2 sided
0.005786
Superiority
OG002
OG005
t-test, 2 sided
0.954163
Superiority
35
OG00435
OG00535
97.04
± 13.397
OG004101.43± 11.116
OG00598.21± 13.165
34
OG00434
OG00534
91.13
± 14.689
OG00497.91± 14.527
OG00597.61± 15.420
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1
ANCOVA
0.077
Mean Difference (Net)
-5.08
Standard Error of the Mean
2.851
2-Sided
95
-10.7083
0.5508
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1
ANCOVA
0.399
Mean Difference (Net)
-2.41
Standard Error of the Mean
2.851
2-Sided
95
-8.0399
3.2192
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1
ANCOVA
0.802
Mean Difference (Net)
0.72
Standard Error of the Mean
2.851
2-Sided
95
-4.9144
6.3446
Superiority
33
OG00433
OG00533
68.36
± 20.387
OG00482.63± 17.149
OG00589.77± 17.470
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2
ANCOVA
<0.001
Mean Difference (Net)
-12.68
Standard Error of the Mean
3.038
2-Sided
95
-18.6789
-6.6775
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2
ANCOVA
0.521
Mean Difference (Net)
-1.96
Standard Error of the Mean
3.038
2-Sided
95
-7.9571
4.0444
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2
ANCOVA
0.006
Mean Difference (Net)
8.39
Standard Error of the Mean
3.038
2-Sided
95
2.3925
14.3940
Superiority
33
OG00433
OG00533
50.81
± 20.377
OG00468.49± 27.025
OG00589.27± 18.969
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3
ANCOVA
<0.001
Mean Difference (Net)
-27.30
Standard Error of the Mean
4.847
2-Sided
95
-36.8727
-17.7298
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3
ANCOVA
0.005
Mean Difference (Net)
-13.71
Standard Error of the Mean
4.847
2-Sided
95
-23.2784
-4.1355
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3
ANCOVA
0.039
Mean Difference (Net)
10.07
Standard Error of the Mean
4.847
2-Sided
95
0.4969
19.6398
Superiority
34
OG00434
OG00534
35.19
± 20.969
OG00456.14± 28.921
OG00582.46± 28.101
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4
ANCOVA
<0.001
Mean Difference (Net)
-37.84
Standard Error of the Mean
5.390
2-Sided
95
-48.4787
-27.1959
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4
ANCOVA
<0.001
Mean Difference (Net)
-20.99
Standard Error of the Mean
5.390
2-Sided
95
-31.6336
-10.3508
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4
ANCOVA
0.106
Mean Difference (Net)
8.75
Standard Error of the Mean
5.390
2-Sided
95
-1.8871
19.3957
Superiority
33
OG00433
OG00533
32.27
± 23.068
OG00444.91± 32.510
OG00567.46± 27.159
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5
ANCOVA
<0.001
Mean Difference (Net)
-27.31
Standard Error of the Mean
5.276
2-Sided
95
-37.7279
-16.8868
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5
ANCOVA
<0.001
Mean Difference (Net)
-18.76
Standard Error of the Mean
5.276
2-Sided
95
-29.1785
-8.3374
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5
ANCOVA
0.200
Mean Difference (Net)
6.79
Standard Error of the Mean
5.276
2-Sided
95
-3.6303
17.2107
Superiority
32
OG00432
OG00532
22.81
± 11.897
OG00431.57± 17.810
OG00553.56± 28.390
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6
ANCOVA
<0.001
Mean Difference (Net)
-25.33
Standard Error of the Mean
4.371
2-Sided
95
-33.9669
-16.6993
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6
ANCOVA
<0.001
Mean Difference (Net)
-20.63
Standard Error of the Mean
4.371
2-Sided
95
-29.2588
-11.9912
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6
ANCOVA
0.330
Mean Difference (Net)
4.27
Standard Error of the Mean
4.371
2-Sided
95
-4.3620
12.9055
Superiority
33
OG00433
OG00533
19.52
± 7.545
OG00425.08± 17.171
OG00539.03± 25.197
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7
ANCOVA
0.002
Mean Difference (Net)
-11.54
Standard Error of the Mean
3.754
2-Sided
95
-18.9563
-4.1302
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7
ANCOVA
0.008
Mean Difference (Net)
-10.07
Standard Error of the Mean
3.754
2-Sided
95
-17.4867
-2.6606
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7
ANCOVA
0.069
Mean Difference (Net)
6.87
Standard Error of the Mean
3.754
2-Sided
95
-0.5447
14.2814
Superiority
33
OG00433
OG00533
16.10
± 15.442
OG00410.07± 4.165
OG00516.45± 5.432
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14
ANCOVA
0.804
Mean Difference (Net)
0.81
Standard Error of the Mean
3.244
2-Sided
95
-5.6006
7.2129
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14
ANCOVA
0.005
Mean Difference (Net)
-9.32
Standard Error of the Mean
3.244
2-Sided
95
-15.7231
-2.9096
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14
ANCOVA
0.985
Mean Difference (Net)
0.06
Standard Error of the Mean
3.244
2-Sided
95
-6.3452
6.4683
Superiority
30
OG00431
OG00529
1.00
± 0.198
OG0040.99± 0.171
OG0050.98± 0.179
27
OG00427
OG00527
1.12
± 0.197
OG0041.15± 0.178
OG0051.22± 0.186
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1
ANCOVA
0.019
Mean Difference (Net)
-0.10
Standard Error of the Mean
0.044
2-Sided
95
-0.1904
-0.0178
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1
ANCOVA
0.183
Mean Difference (Net)
-0.06
Standard Error of the Mean
0.043
2-Sided
95
-0.1437
0.0278
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1
ANCOVA
0.736
Mean Difference (Net)
0.01
Standard Error of the Mean
0.044
2-Sided
95
-0.0725
0.1023
Superiority
27
OG00427
OG00527
1.07
± 0.188
OG0041.18± 0.218
OG0051.37± 0.212
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2
ANCOVA
0.006
Mean Difference (Net)
-0.14
Standard Error of the Mean
0.052
2-Sided
95
-0.2459
-0.0412
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2
ANCOVA
0.671
Mean Difference (Net)
-0.02
Standard Error of the Mean
0.051
2-Sided
95
-0.1235
0.0798
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2
ANCOVA
0.004
Mean Difference (Net)
0.15
Standard Error of the Mean
0.052
2-Sided
95
0.0504
0.2578
Superiority
16
OG00417
OG00515
1.06
± 0.174
OG0041.16± 0.160
OG0051.33± 0.252
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3
ANCOVA
0.016
Mean Difference (Net)
-0.15
Standard Error of the Mean
0.062
2-Sided
95
-0.2773
-0.0297
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3
ANCOVA
0.538
Mean Difference (Net)
-0.04
Standard Error of the Mean
0.062
2-Sided
95
-0.1622
0.0853
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3
ANCOVA
0.061
Mean Difference (Net)
.012
Standard Error of the Mean
0.065
2-Sided
95
-0.0059
0.2515
Superiority
34
OG00433
OG00534
0.99
± 0.205
OG0041.14± 0.386
OG0051.28± 0.252
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4
ANCOVA
<0.001
Mean Difference (Net)
-0.24
Standard Error of the Mean
0.060
2-Sided
95
-0.3614
-0.1243
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4
ANCOVA
0.236
Mean Difference (Net)
-0.07
Standard Error of the Mean
0.060
2-Sided
95
-0.1899
0.0471
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4
ANCOVA
0.627
Mean Difference (Net)
0.03
Standard Error of the Mean
0.061
2-Sided
95
-0.0902
0.1492
Superiority
24
OG00424
OG00523
0.96
± 0.178
OG0041.00± 0.207
OG0051.26± 0.336
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5
ANCOVA
<0.001
Mean Difference (Net)
-0.21
Standard Error of the Mean
0.050
2-Sided
95
-0.3091
-0.1092
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5
ANCOVA
0.005
Mean Difference (Net)
-0.14
Standard Error of the Mean
0.050
2-Sided
95
-0.2439
-0.0457
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5
ANCOVA
0.020
Mean Difference (Net)
0.12
Standard Error of the Mean
0.052
2-Sided
95
0.0197
0.2252
Superiority
29
OG00429
OG00529
0.95
± 0.148
OG0040.98± 0.159
OG0051.23± 0.326
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6
ANCOVA
<0.001
Mean Difference (Net)
-0.27
Standard Error of the Mean
0.050
2-Sided
95
-0.3655
-0.1679
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6
ANCOVA
<0.001
Mean Difference (Net)
-0.24
Standard Error of the Mean
0.050
2-Sided
95
-0.3338
-0.1377
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6
ANCOVA
0.646
Mean Difference (Net)
0.02
Standard Error of the Mean
0.050
2-Sided
95
-0.0767
0.1231
Superiority
33
OG00433
OG00533
0.89
± 0.151
OG0040.88± 0.141
OG0051.03± 0.279
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7
ANCOVA
0.002
Mean Difference (Net)
-0.15
Standard Error of the Mean
0.047
2-Sided
95
-0.2444
-0.0574
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7
ANCOVA
0.001
Mean Difference (Net)
-0.16
Standard Error of the Mean
0.047
2-Sided
95
-0.2541
-0.0682
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7
ANCOVA
0.911
Mean Difference (Net)
0.01
Standard Error of the Mean
0.048
2-Sided
95
-0.0891
0.0998
Superiority
29
OG00429
OG00529
0.85
± 0.125
OG0040.84± 0.112
OG0050.92± 0.115
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14
ANCOVA
0.026
Mean Difference (Net)
-0.09
Standard Error of the Mean
0.039
2-Sided
95
-0.1663
-0.0108
Superiority
OG001
OG004
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14
ANCOVA
0.045
Mean Difference (Net)
-0.08
Standard Error of the Mean
0.039
2-Sided
95
-0.1562
-0.0017
Superiority
OG001
OG005
Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14