Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide... | NCT00713609 | Trialant
NCT00713609
Sponsor
Stiefel, a GSK Company
Status
Completed
Last Update Posted
Mar 6, 2017Actual
Enrollment
591Actual
Phase
Phase 2
Conditions
Acne Vulgaris
Interventions
Benzoyl peroxide gel
Clindamycin gel
Tazarotene cream
Vehicle gel
Vehicle cream
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00713609
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
114570
Secondary IDs
Not provided
Brief Title
Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
Official Title
A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jan 2017
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
Jun 2008
Primary Completion Date
Mar 2009Actual
Completion Date
Mar 2009Actual
First Submitted Date
Jul 7, 2008
First Submission Date that Met QC Criteria
Jul 7, 2008
First Posted Date
Jul 11, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 12, 2016
Results First Submitted that Met QC Criteria
Jan 13, 2017
Results First Posted Date
Mar 6, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 7, 2010
Certification/Extension First Submitted that Passed QC Review
Sep 7, 2010
Certification/Extension First Posted Date
Sep 9, 2010Estimated
Last Update Submitted Date
Jan 13, 2017
Last Update Posted Date
Mar 6, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Stiefel, a GSK CompanyINDUSTRY
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris.
You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.
Detailed Description
The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks.
Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.
Conditions Module
Conditions
Acne Vulgaris
Keywords
Acne
Acne Vulgaris
Pimples
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
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
591Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Experimental
Benzoyl peroxide/clindamycin gel + tazarotene cream
Drug: Benzoyl peroxide gel
Drug: Clindamycin gel
Drug: Tazarotene cream
2
Active Comparator
Benzoyl peroxide/clindamycin gel + vehicle cream
Drug: Benzoyl peroxide gel
Drug: Clindamycin gel
Drug: Vehicle cream
3
Active Comparator
Benzoyl peroxide gel + tazarotene cream
Drug: Benzoyl peroxide gel
Drug: Tazarotene cream
4
Active Comparator
Clindamycin gel + tazarotene cream
Drug: Clindamycin gel
Drug: Tazarotene cream
5
Active Comparator
Vehicle gel+ tazarotene cream
Drug: Tazarotene cream
Drug: Vehicle gel
6
Placebo Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Benzoyl peroxide gel
Drug
5% benzoyl peroxide in a gel applied topically once a day
1
2
3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Baseline and up to Week 12
Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Baseline and up to Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria: Subjects must be males or females 12 to 45 years of age.
Subjects must have acne on their face.
Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit.
Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements).
Subjects must be able to complete the study and to comply with study instructions.
Exclusion Criteria:
Subjects who are pregnant, trying to become pregnant, or breast-feeding.
Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination
History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products
Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months.
Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study.
Other exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
45 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Dermatology Research of Arkansas
Little Rock
Arkansas
72205
United States
Center for Dermatology Cosmetic and Laser Surgery
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.
Results Section
Participant Flow Module
Pre-assignment Details
Participants with facial acne vulgaris, 12 to 45 years of age were enrolled in this study. A total of 596 participants were randomized and 587 participants received study product.
Recruitment Details
In this multi-center, double-blind, vehicle controlled study, participants were assigned to one of the six treatment groups in a 2:2:2:2:2:1 ratio for 12 weeks.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Benzoyl Peroxide/Clindamycin + Tazarotene
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face
1% clindamycin phosphate applied topically once a day
1
2
4
Tazarotene cream
Drug
0.1 % tazarotene in a cream applied topically once a day
1
3
4
5
Vehicle gel
Drug
Vehicle gel is an identical gel without the active ingredients
5
6
Vehicle cream
Drug
Vehicle cream is an identical cream without the active ingredients
2
6
Baseline and up to Week 12
Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
Week 12
Fremont
California
94538
United States
Center for Dermatology and Laser Surgery
Sacramento
California
95819
United States
Boulder Medical Center, P.C.
Boulder
Colorado
80304
United States
Dermatology Associates Research
Coral Gables
Florida
33134
United States
MedaPhase, Inc.
Newnan
Georgia
30263
United States
Callender Center for Clinical Research
Mitchellville
Maryland
20721
United States
Grekin Skin Institute
Warren
Michigan
48088
United States
University of North Carolina Chapel Hill
Chapel Hill
North Carolina
27599
United States
Dermatology Consulting Services
High Point
North Carolina
27262
United States
MS Hershey Medical Center
Hershey
Pennsylvania
17033
United States
Rivergate Dermatology & Skin Care Center
Goodlettsville
Tennessee
37072
United States
The Skin Wellness Center, PC
Knoxville
Tennessee
37922
United States
Dermatology Treatment & Research Center
Dallas
Texas
75230
United States
Suzanne Bruce and Associates, PA
Houston
Texas
77056
United States
Dermatology Clinical Research Center of San Antonio
San Antonio
Texas
78229
United States
FG001
Benzoyl Peroxide/Clindamycin + Vehicle Cream
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
FG002
Benzoyl Peroxide Gel + Tazarotene
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
FG003
Clindamycin Gel + Tazarotene
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
FG004
Vehicle Gel + Tazarotene
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
FG005
Vehicle Gel + Vehicle Cream
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
FG000106 subjects
FG001105 subjects
FG002107 subjects
FG003108 subjects
FG004106 subjects
FG00555 subjects
COMPLETED
FG00085 subjects
FG00190 subjects
FG00292 subjects
FG00399 subjects
FG00487 subjects
FG00547 subjects
NOT COMPLETED
FG00021 subjects
FG00115 subjects
FG00215 subjects
FG0039 subjects
FG00419 subjects
FG0058 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG0043 subjects
FG0051 subjects
Lost to Follow-up
FG0005 subjects
FG0017 subjects
FG0025 subjects
FG0035 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-Compliance with Study Treatment
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0011 subjects
FG0025 subjects
FG0031 subjects
FG004
Protocol Violation
FG0006 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Benzoyl Peroxide/Clindamycin + Tazarotene
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face
BG001
Benzoyl Peroxide/Clindamycin + Vehicle Cream
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
BG002
Benzoyl Peroxide Gel + Tazarotene
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
BG003
Clindamycin Gel + Tazarotene
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
BG004
Vehicle Gel + Tazarotene
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
BG005
Vehicle Gel + Vehicle Cream
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000106
BG001105
BG002107
BG003108
BG004106
BG00555
BG006587
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00019.7± 6.6
BG00119.7± 6.9
BG00220.2± 7.3
BG003
Gender
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00058
BG00156
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0001
BG0010
BG002
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
Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
Intent-to-treat (ITT) Analysis Set: all randomized participants who received study product and reached Week 12.
Posted
Mean
Standard Deviation
Lesion count
Baseline and up to Week 12
ID
Title
Description
OG000
Benzoyl Peroxide/Clindamycin + Tazarotene
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG001
Benzoyl Peroxide/Clindamycin + Vehicle Cream
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG002
Benzoyl Peroxide Gel + Tazarotene
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG003
Clindamycin Gel + Tazarotene
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG004
Vehicle Gel + Tazarotene
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG005
Vehicle Gel + Vehicle Cream
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Units
Counts
Participants
OG000106
OG001105
OG002107
OG003
Title
Denominators
Categories
ILC, n=101, 103, 105, 105, 104, 52
Title
Measurements
OG000-16.8± 14.35
OG001-18.1± 14.45
OG002-18.9± 12.84
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
OG000
OG001
ANCOVA
0.692
For ILC
No
Superiority or Other
OG000
OG002
ANCOVA
0.467
Primary
Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
ITT Analysis Set
Posted
Number
Percentage of participants
Baseline and up to Week 12
ID
Title
Description
OG000
Benzoyl Peroxide/Clindamycin + Tazarotene
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG001
Benzoyl Peroxide/Clindamycin + Vehicle Cream
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Secondary
Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory)
The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles).
ITT Analysis Set
Posted
Mean
Standard Deviation
Percent change
Baseline and up to Week 12
ID
Title
Description
OG000
Benzoyl Peroxide/Clindamycin + Tazarotene
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG001
Benzoyl Peroxide/Clindamycin + Vehicle Cream
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Secondary
Proportion of Participants With an ISGA Score of 0 or 1 at Week 12
An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed.
ITT Analysis Set
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
Benzoyl Peroxide/Clindamycin + Tazarotene
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG001
Benzoyl Peroxide/Clindamycin + Vehicle Cream
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Time Frame
Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from Day 1 up to Day 89.
Description
SAEs and non-serious AEs were assessed in the ITT Analysis Set.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Benzoyl Peroxide/Clindamycin + Tazarotene
Participants applied the study product (Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 grams [g] of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
0
106
25
106
EG001
Benzoyl Peroxide/Clindamycin + Vehicle Cream
Participants applied the study product (Benzoyl peroxide/Clindamycin + vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
0
105
22
105
EG002
Benzoyl Peroxide Gel + Tazarotene
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
0
107
24
107
EG003
Clindamycin Gel + Tazarotene
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
0
108
18
108
EG004
Vehicle Gel + Tazarotene
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
0
106
29
106
EG005
Vehicle Gel + Vehicle Cream
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
0
55
12
55
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Conjunctivitis
Eye disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG0030 affected108 at risk
EG0040 affected106 at risk
EG0050 affected55 at risk
Aphthous stomatitis
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Lip blister
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Tooth impacted
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Application site burn
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Application site dermatitis
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Application site discolouration
General disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Application site dryness
General disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Application site erythema
General disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0022 affected107 at risk
EG003
Application site exfoliation
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Application site irritation
General disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0023 affected107 at risk
EG003
Application site pain
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0022 affected107 at risk
EG003
Application site pruritus
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Condition aggravated
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Cyst
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Local swelling
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Pain
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Pyrexia
General disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Allergy to arthropod bite
Immune system disorders
MedDRA 10.1
Systematic Assessment
EG0002 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Allergy to metals
Immune system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Food allergy
Immune system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Multiple allergies
Immune system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Ear infection
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Furuncle
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0021 affected107 at risk
EG003
Influenza
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Localised infection
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Lyme disease
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0003 affected106 at risk
EG0013 affected105 at risk
EG0023 affected107 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0011 affected105 at risk
EG0022 affected107 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0005 affected106 at risk
EG0014 affected105 at risk
EG0025 affected107 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Vaginitis bacterial
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Viral infection
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0021 affected107 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Smear cervix abnormal
Investigations
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Fibromatosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Headache
Nervous system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Insomnia
Nervous system disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0023 affected107 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0021 affected107 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0001 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0010 affected105 at risk
EG0020 affected107 at risk
EG003
Wisdom teeth removal
Surgical and medical procedures
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0020 affected107 at risk
EG003
Hypotension
Vascular disorders
MedDRA 10.1
Systematic Assessment
EG0000 affected106 at risk
EG0011 affected105 at risk
EG0021 affected107 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG003
Clindamycin Gel + Tazarotene
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG004
Vehicle Gel + Tazarotene
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG005
Vehicle Gel + Vehicle Cream
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Units
Counts
Participants
OG000106
OG001105
OG002107
OG003108
OG004106
OG00555
Title
Denominators
Categories
Title
Measurements
OG00022
OG00122
OG00231
OG00336
OG00420
OG0055
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
Cochran-Mantel-Haenszel
0.922
No
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
0.132
No
Superiority or Other
OG000
OG003
Cochran-Mantel-Haenszel
0.020
No
Superiority or Other
OG000
OG004
Cochran-Mantel-Haenszel
0.706
No
Superiority or Other
OG000
OG005
Cochran-Mantel-Haenszel
0.009
No
Superiority or Other
OG002
Benzoyl Peroxide Gel + Tazarotene
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG003
Clindamycin Gel + Tazarotene
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG004
Vehicle Gel + Tazarotene
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG005
Vehicle Gel + Vehicle Cream
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
Units
Counts
Participants
OG000106
OG001105
OG002107
OG003108
OG004106
OG00555
Title
Denominators
Categories
ILC, n=101, 103, 105, 105, 104, 52
Title
Measurements
OG000-58.3± 45.57
OG001-62.4± 39.33
OG002-62.4± 34.83
OG003-65.7± 33.38
OG004-49.0± 40.90
OG005-33.5± 41.10
NILC, n=101, 103, 105, 105, 104, 52
Title
Measurements
OG000-58.0± 29.97
OG001-39.2± 51.29
OG002-60.6± 35.00
OG003
TLC, n=101, 103, 105, 105, 104, 52
Title
Measurements
OG000-59.1± 29.96
OG001-47.9± 38.89
OG002-62.0± 29.42
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
OG000
OG001
ANCOVA
0.504
For ILC
No
Superiority or Other
OG000
OG002
ANCOVA
0.504
For ILC
No
Superiority or Other
OG000
OG003
ANCOVA
0.177
For ILC
No
Superiority or Other
OG000
OG004
ANCOVA
0.084
For ILC
No
Superiority or Other
OG000
OG005
ANCOVA
<0.001
For ILC
No
Superiority or Other
OG000
OG001
ANCOVA
<0.001
For NILC
No
Superiority or Other
OG000
OG002
ANCOVA
0.776
For NILC
No
Superiority or Other
OG000
OG003
ANCOVA
0.465
For NILC
No
Superiority or Other
OG000
OG004
ANCOVA
0.288
For NILC
No
Superiority or Other
OG000
OG005
ANCOVA
<0.001
For NILC
No
Superiority or Other
OG000
OG001
ANCOVA
0.006
For TC
No
Superiority or Other
OG000
OG002
ANCOVA
0.620
For TC
No
Superiority or Other
OG000
OG003
ANCOVA
0.291
For TC
No
Superiority or Other
OG000
OG004
ANCOVA
0.085
For TC
No
Superiority or Other
OG000
OG005
ANCOVA
<0.001
For TC
No
Superiority or Other
OG002
Benzoyl Peroxide Gel + Tazarotene
Participants applied the study product (Benzoyl peroxide gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG003
Clindamycin Gel + Tazarotene
Participants applied the study product (Clindamycin gel + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG004
Vehicle Gel + Tazarotene
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin + Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.
OG005
Vehicle Gel + Vehicle Cream
Participants applied the study product (Vehicle gel with identical ingredients as Benzoyl peroxide/Clindamycin+ vehicle cream with identical ingredients as Tazarotene) to the face once daily in the evening up to 12 weeks. Two actuations of test product (approximately 0.6 g of the combined product in an approximate 1:1 ratio) were dispensed into the participant's palm and mixed. A thin film was then applied to the entire face.