An Efficiency of a Moisturizer Containing Licochalcone A,... | NCT02173054

An Efficiency of a Moisturizer Containing Licochalcone A,... | NCT02173054 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adapalene gel	Placebo Comparator	Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face	Other: Adapalene gel
Adapalene gel with placebo moisturizer	Placebo Comparator	Morning Wash face by prepared facial foam and dry their face Apply placebo cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply placebo cream all over the face	Other: Adapalene gel with placebo moisturizer
Adapalene gel with Eucerin	Active Comparator	Morning Wash face by prepared facial foam and dry their face Apply Eucerin cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply Eucerin cream all over the face	Other: Adapalene gel with Eucerin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adapalene gel with Eucerin	Other	Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of Undesirable Effects	Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week. The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown.	2nd week, 4th week, and 8th week
Skin Tolerability: Skin Sebum Content and Skin Hydration	Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively	Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.
Skin Tolerability: Transepidermal Water Loss (TEWL)	Skin tolerability was assessed by measuring TEWL with the Tewameter TM300	Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.

Secondary Outcomes

Measure	Description	Time Frame
Reduction of Severity of Acne	Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks Total acne lesions = inflammatory + noninflammatory acne lesions Reduction of lesions counts are considered to be a better outcome	baseline, 2nd week, 4th week and 8th week

Contacts/Locations Module

Name	Affiliation	Role
Papapit Tuchinda, MD	Mahidol University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj Hospital Mahidol Univeristy		Bangkok	Bangkok	10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26293170	Derived	Chularojanamontri L, Tuchinda P, Kulthanan K, Varothai S, Winayanuwattikun W. A double-blinded, randomized, vehicle-controlled study to access skin tolerability and efficacy of an anti-inflammatory moisturizer in treatment of acne with 0.1% adapalene gel. J Dermatolog Treat. 2016;27(2):140-5. doi: 10.3109/09546634.2015.1079298. Epub 2015 Sep 2.

Arm/Group Information

ID	Title	Description
FG000	Adapalene Gel	Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
FG001	Adapalene Gel With Placebo Moisturizer	Morning Wash face by prepared facial foam and dry their face Apply placebo cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply placebo cream all over the face Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
FG002	Adapalene Gel With Eucerin	Morning Wash face by prepared facial foam and dry their face Apply Eucerin cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply Eucerin cream all over the face Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00040 subjects FG00140 subjects FG00240 subjects
COMPLETED		FG00039 subjects FG00140 subjects FG00239 subjects
NOT COMPLETED		FG0001 subjects FG0010 subjects FG0021 subjects

Type	Comment	Reasons
lack of compliance		FG0001 subjects FG0010 subjects FG0020 subjects
Withdrawal by Subject		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Adapalene Gel	Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
BG001	Adapalene Gel With Placebo Moisturizer

Units	Counts
Participants	BG000

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

Reduction of Undesirable Effects

Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week.
The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown.

The reasons for drop out were lack of compliance (n=1, group A: adapalene gel alone) and consent withdrawal at patient's request (n=1, group C: adapalene with Eucerin)

Posted

Number

participants

2nd week, 4th week, and 8th week

ID	Title	Description
OG000	Adapalene Gel	Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Adverse Events Module

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	Adapalene Gel	Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Papapit Tuchinda	Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University	+662-419-4333		papapitt@gmail.com

Condition Browse Module

ID	Term
D000152	Acne Vulgaris

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Intervention Browse Module

ID	Term
C039909	eucerin
C070840	licochalcone A
D002331	Carnitine
D000068816	Adapalene

ID	Term
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

Title

Denominators

Categories

Erythema (none)

Title	Measurements
	OG00026 OG00138 OG00235

Erythema (mild)

Title	Measurements
	OG00010 OG0012 OG0024

Erythema (moderate)

Title	Measurements
	OG0003 OG0010 OG0020

Dryness (none)

Title	Measurements
	OG00021 OG00129 OG00232

Dryness (mild)

Title	Measurements
	OG00014 OG00111 OG0026

Dryness (moderate)

Title	Measurements
	OG0004 OG0010 OG0021

Scaling (none)

Title	Measurements
	OG00013 OG00116 OG00224

Scaling (mild)

Title	Measurements
	OG00022 OG00124 OG00214

Scaling (moderate)

Title	Measurements
	OG0004 OG0010 OG0021

Stinging (none)

Title	Measurements
	OG0006 OG0019 OG0026

Stinging (mild)

Title	Measurements
	OG00014 OG00112 OG00211

Stinging (moderate)

Title	Measurements
	OG00010 OG00113 OG00213

Stinging (severe)

Title	Measurements
	OG0009 OG0016 OG0029

Pruritus (none)

Title	Measurements
	OG00018 OG00121 OG00223

Pruritus (mild)

Title	Measurements
	OG00010 OG0018 OG0029

Pruritus (moderate)

Title	Measurements
	OG0007 OG0016 OG0025

Pruritus (severe)

Title	Measurements
	OG0004 OG0015 OG0022

Group IDs	Statistical Method	P-Value	P-Value Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001 OG002	Kruskal-Wallis	0.001	This statistical analysis was used to compare number of participants who had erythema among 3 groups.	No	Superiority or Other
OG000 OG001 OG002	Kruskal-Wallis	0.016	This statistical analysis was used to compare number of participants who had dryness among 3 groups	No	Superiority or Other
OG000 OG001 OG002	Kruskal-Wallis	0.025	This statistical analysis was used to compare number of participants who had scaling among 3 groups.	No	Superiority or Other
OG000 OG001 OG002	Kruskal-Wallis	0.571	This statistical analysis was used to compare number of participants who had stinging among 3 groups.	No	Superiority or Other
OG000 OG001 OG002	Kruskal-Wallis	0.449	This statistical analysis was used to compare number of participants who had pruritus among 3 groups.	No	Superiority or Other

Secondary

Reduction of Severity of Acne

Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks
Total acne lesions = inflammatory + noninflammatory acne lesions
Reduction of lesions counts are considered to be a better outcome

Posted

Mean

Standard Deviation

Lesions

baseline, 2nd week, 4th week and 8th week

ID	Title	Description
OG000	Adapalene Gel	Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
OG001	Adapalene Gel With Placebo Moisturizer	Morning Wash face by prepared facial foam and dry their face Apply placebo cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply placebo cream all over the face Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
OG002	Adapalene Gel With Eucerin	Morning Wash face by prepared facial foam and dry their face Apply Eucerin cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply Eucerin cream all over the face Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Units	Counts
Participants	OG00039 OG00140 OG00239

Title

Denominators

Categories

Baseline Total Lesion Count

Title	Measurements
	OG00035.9± 49.1 OG00127.4± 37.0 OG00225.5± 16.9

Week 2 Total Lesion Count

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		wilcoxan signed ranks test		0.059	This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week												No	Superiority or Other
OG001		wilcoxan signed ranks test

Primary

Skin Tolerability: Skin Sebum Content and Skin Hydration

Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively

Posted

Mean

Standard Deviation

µg/cm^2

Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.

ID	Title	Description
OG000	Adapalene Gel	Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
OG001	Adapalene Gel With Placebo Moisturizer	Morning Wash face by prepared facial foam and dry their face Apply placebo cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply placebo cream all over the face Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
OG002	Adapalene Gel With Eucerin	Morning Wash face by prepared facial foam and dry their face Apply Eucerin cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply Eucerin cream all over the face Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Units	Counts
Participants	OG00039 OG00140 OG00239

Title

Denominators

Categories

Baseline Sebumeter

Title	Measurements
	OG00075.7± 34.4 OG00171.2± 42.4 OG00273.7± 31.2

Week 8 Sebumeter

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		Paired t-test		0.078	This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel group												No	Superiority or Other
OG001		Paired t-test

Primary

Skin Tolerability: Transepidermal Water Loss (TEWL)

Skin tolerability was assessed by measuring TEWL with the Tewameter TM300

Posted

Mean

Standard Deviation

g/m^2h

Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.

ID	Title	Description
OG000	Adapalene Gel	Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
OG001	Adapalene Gel With Placebo Moisturizer	Morning Wash face by prepared facial foam and dry their face Apply placebo cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply placebo cream all over the face Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
OG002	Adapalene Gel With Eucerin	Morning Wash face by prepared facial foam and dry their face Apply Eucerin cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply Eucerin cream all over the face Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Units	Counts
Participants	OG00039 OG00140 OG00239

Title

Denominators

Categories

Baseline TEWL

Title	Measurements
	OG0009.8± 3.3 OG00110.4± 4.6 OG00210.6± 3.7

Week 8 TEWL

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		Paired t-test		0.0002	This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel group.												No	Superiority or Other
OG001		Paired t-test

Secondary

Reduction of Severity of Acne: Acne Severity Index (ASI)

The ASI score was calculated from the number of papules + (2 x pustules) + (comedones/4)
Decrease of ASI score are considered to be a better outcome

Posted

Mean

Standard Deviation

units on a scale

baseline, 2nd week, 4th week and 8th week

ID	Title	Description
OG000	Adapalene Gel	Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
OG001	Adapalene Gel With Placebo Moisturizer	Morning Wash face by prepared facial foam and dry their face Apply placebo cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply placebo cream all over the face Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
OG002	Adapalene Gel With Eucerin	Morning Wash face by prepared facial foam and dry their face Apply Eucerin cream all over the face Evening Wash face by prepared facial foam and dry your face Apply adapalene gel all over the face Apply Eucerin cream all over the face Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed

Units	Counts
Participants	OG00039 OG00140 OG00239

Title

Denominators

Categories

Baseline ASI

Title	Measurements
	OG00011.7± 13.6 OG0019.4± 9.5 OG0029.5± 5.8

Week 2 ASI

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		wilcoxan signed ranks test		0.005	This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.												No	Superiority or Other
OG001		wilcoxan signed ranks test