An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne - Study Results

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Acne
Interventions	Other: Adapalene gel with Eucerin Other: Adapalene gel Other: Adapalene gel with placebo moisturizer
Enrollment	120

Participant Flow

Recruitment Details	The recruitment period: between June 2014 and December 2014 Location: Department of Dermatology, Siriraj Hospital, Mahidol University, Thailand
Pre-assignment Details


Arm/Group Title	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
Arm/Group Description	Evening ...	Morning ...	Morning ...
Arm/Group Description	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	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	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
Period Title: Overall Study
Started	40	40	40
Completed	39	40	39
Not Completed	1	0	1
Reason Not Completed
lack of compliance	1	0	0
Withdrawal by Subject	0	0	1

Baseline Characteristics

Arm/Group Title		Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin	Total
Arm/Group Description		Evening ...	Morning ...	Morning ...	Total of all reporting groups
Arm/Group Description		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	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	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	Total of all reporting groups
Overall Number of Baseline Participants		40	40	40	120
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Full Range) Unit of measure: Years
	Number Analyzed	40 participants	40 participants	40 participants	120 participants
		27.3 (19 to 43)	27.2 (20 to 40)	28.1 (18 to 49)	27.5 (18 to 49)
Gender Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	40 participants	40 participants	40 participants	120 participants
	Female	22 55.0%	19 47.5%	26 65.0%	67 55.8%
	Male	18 45.0%	21 52.5%	14 35.0%	53 44.2%
Region of Enrollment Measure Type: Number Unit of measure: Participants
Thailand	Number Analyzed	40 participants	40 participants	40 participants	120 participants
Thailand		40	40	40	120

Outcome Measures

1.Primary Outcome


Title	Reduction of Undesirable Effects
Description	...
Description	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.
Time Frame	2nd week, 4th week, and 8th week

Outcome Measure Data

Analysis Population Description

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)


Arm/Group Title	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
Arm/Group Description:	Evening ...	Morning ...	Morning ...
Arm/Group Description:	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	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	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
Overall Number of Participants Analyzed	39	40	39
Measure Type: Number Unit of Measure: participants
Erythema (none)	26	38	35
Erythema (mild)	10	2	4
Erythema (moderate)	3	0	0
Dryness (none)	21	29	32
Dryness (mild)	14	11	6
Dryness (moderate)	4	0	1
Scaling (none)	13	16	24
Scaling (mild)	22	24	14
Scaling (moderate)	4	0	1
Stinging (none)	6	9	6
Stinging (mild)	14	12	11
Stinging (moderate)	10	13	13
Stinging (severe)	9	6	9
Pruritus (none)	18	21	23
Pruritus (mild)	10	8	9
Pruritus (moderate)	7	6	5
Pruritus (severe)	4	5	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	This statistical analysis was used to compare number of participants who had erythema among 3 groups.
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.016
	Comments	This statistical analysis was used to compare number of participants who had dryness among 3 groups
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.025
	Comments	This statistical analysis was used to compare number of participants who had scaling among 3 groups.
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.571
	Comments	This statistical analysis was used to compare number of participants who had stinging among 3 groups.
	Method	Kruskal-Wallis
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel, Adapalene Gel With Placebo Moisturizer, Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.449
	Comments	This statistical analysis was used to compare number of participants who had pruritus among 3 groups.
	Method	Kruskal-Wallis
	Comments	[Not Specified]

2.Primary Outcome


Title	Skin Tolerability: Skin Sebum Content and Skin Hydration
Description	Skin tolerability was assessed by measuring the skin surface sebum con...
Description	Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
Arm/Group Description:	Evening ...	Morning ...	Morning ...
Arm/Group Description:	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	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	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
Overall Number of Participants Analyzed	39	40	39
Mean (Standard Deviation) Unit of Measure: µg/cm^2
Baseline Sebumeter	75.7 (34.4)	71.2 (42.4)	73.7 (31.2)
Week 8 Sebumeter	63.6 (31.7)	59.9 (55.3)	64.2 (35.0)
Baseline Corneometer	51.7 (10.0)	50.2 (10.5)	46.7 (11.3)
Week 8 Corneometer	50.9 (10.9)	49.5 (9.4)	48.6 (9.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.078
	Comments	This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel group
	Method	Paired t-test
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Placebo Moisturizer
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.167
	Comments	This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with placebo moisturizer group
	Method	Paired t-test
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.134
	Comments	This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with Eucerin group
	Method	Paired t-test
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.978
	Comments	This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel group
	Method	Paired t-test
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Placebo Moisturizer
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.273
	Comments	This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with placebo moisturizer group
	Method	Paired t-test
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.735
	Comments	This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with Eucerin group.
	Method	Paired t-test
	Comments	[Not Specified]

3.Primary Outcome


Title	Skin Tolerability: Transepidermal Water Loss (TEWL)
Description	Skin tolerability was assessed by measuring TEWL with the Tewameter TM...
Description	Skin tolerability was assessed by measuring TEWL with the Tewameter TM300
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
Arm/Group Description:	Evening ...	Morning ...	Morning ...
Arm/Group Description:	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	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	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
Overall Number of Participants Analyzed	39	40	39
Mean (Standard Deviation) Unit of Measure: g/m^2h
Baseline TEWL	9.8 (3.3)	10.4 (4.6)	10.6 (3.7)
Week 8 TEWL	12.3 (4.8)	11.8 (5.4)	11.5 (3.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0002
	Comments	This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel group.
	Method	Paired t-test
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Placebo Moisturizer
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.007
	Comments	This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with placebo moisturizer group.
	Method	Paired t-test
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.123
	Comments	This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with Eucerin group.
	Method	Paired t-test
	Comments	[Not Specified]

4.Secondary Outcome


Title	Reduction of Severity of Acne
Description	...
Description	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
Time Frame	baseline, 2nd week, 4th week and 8th week

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
Arm/Group Description:	Evening ...	Morning ...	Morning ...
Arm/Group Description:	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	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	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
Overall Number of Participants Analyzed	39	40	39
Mean (Standard Deviation) Unit of Measure: Lesions
Baseline Total Lesion Count	35.9 (49.1)	27.4 (37.0)	25.5 (16.9)
Week 2 Total Lesion Count	41 (65.7)	26.6 (29.3)	23.8 (16.6)
Week 4 Total Lesion Count	39 (54.2)	27.3 (25.2)	25.7 (16.7)
Week 8 Total Lesion Count	28.9 (33.3)	26.8 (22.5)	19.9 (15.2)
Baseline Inflammatory Lesion Counts	3.5 (3.9)	3 (2.6)	3.8 (3.3)
Week 2 Inflammatory Lesion Counts	4.5 (6.6)	4.1 (7.4)	3.6 (3.9)
Week 4 Inflammatory Lesion Counts	3.6 (5.4)	2.9 (2.9)	3.4 (3.5)
Week 8 Inflammatory Lesion Counts	2.5 (5.6)	3.1 (4.1)	2.4 (3.0)
Baseline Noninflammatory Counts	32.4 (48.0)	24.5 (37.3)	21.6 (16.2)
Week 2 Noninflammatory Counts	36.5 (61.9)	22.5 (28.1)	20.5 (15.3)
Week 4 Noninflammatory Counts	35.4 (50.6)	24.4 (24.4)	22.6 (16.1)
Week 8 Noninflammatory Counts	26.4 (29.1)	23.7 (20.1)	17.7 (14.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.059
	Comments	This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Placebo Moisturizer
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.697
	Comments	This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.028
	Comments	This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Placebo Moisturizer
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.755
	Comments	This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.003
	Comments	This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.205
	Comments	This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Placebo Moisturizer
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.576
	Comments	This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.160
	Comments	This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

5.Secondary Outcome


Title	Reduction of Severity of Acne: Acne Severity Index (ASI)
Description	...
Description	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
Time Frame	baseline, 2nd week, 4th week and 8th week

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
Arm/Group Description:	Evening ...	Morning ...	Morning ...
Arm/Group Description:	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	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	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
Overall Number of Participants Analyzed	39	40	39
Mean (Standard Deviation) Unit of Measure: units on a scale
Baseline ASI	11.7 (13.6)	9.4 (9.5)	9.5 (5.8)
Week 2 ASI	14.4 (20.8)	10.4 (11.3)	8.7 (6.1)
Week 4 ASI	13.6 (19.4)	9.2 (7.5)	9.2 (5.9)
Week 8 ASI	9.5 (13.7)	9.3 (8.5)	7.1 (5.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.005
	Comments	This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Placebo Moisturizer
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.606
	Comments	This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Adapalene Gel With Eucerin
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.
	Method	wilcoxan signed ranks test
	Comments	[Not Specified]

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
Arm/Group Description	Evening ...	Morning ...	Morning ...
Arm/Group Description	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	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	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
All-Cause Mortality
	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/40 (0.00%)	0/40 (0.00%)	0/40 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Adapalene Gel	Adapalene Gel With Placebo Moisturizer	Adapalene Gel With Eucerin
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/40 (0.00%)	0/40 (0.00%)	0/40 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Mahidol University
ClinicalTrials.gov Identifier:	NCT02173054
Other Study ID Numbers:	Acne and adjuctive moisturizer
First Submitted:	June 18, 2014
First Posted:	June 24, 2014
Results First Submitted:	July 29, 2015
Results First Posted:	February 26, 2016
Last Update Posted:	January 23, 2017