Trial Outcomes & Findings for An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne (NCT NCT02173054)

Last Updated: 2017-01-23

Results Overview

* 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

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

Results posted on

2017-01-23

Participant Flow

The recruitment period: between June 2014 and December 2014 Location: Department of Dermatology, Siriraj Hospital, Mahidol University, Thailand

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	40	40	40
Overall Study COMPLETED	39	40	39
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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
Overall Study lack of compliance	1	0	0
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adapalene Gel n=40 Participants 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	Adapalene Gel With Placebo Moisturizer n=40 Participants 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	Adapalene Gel With Eucerin n=40 Participants 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 n=120 Participants Total of all reporting groups
Age, Continuous	27.3 years n=5 Participants	27.2 years n=7 Participants	28.1 years n=5 Participants	27.5 years n=4 Participants
Gender Female	22 Participants n=5 Participants	19 Participants n=7 Participants	26 Participants n=5 Participants	67 Participants n=4 Participants
Gender Male	18 Participants n=5 Participants	21 Participants n=7 Participants	14 Participants n=5 Participants	53 Participants n=4 Participants
Region of Enrollment Thailand	40 participants n=5 Participants	40 participants n=7 Participants	40 participants n=5 Participants	120 participants n=4 Participants

PRIMARY outcome

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

Population: 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)

Outcome measures

Outcome measures
Measure	Adapalene Gel n=39 Participants 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	Adapalene Gel With Placebo Moisturizer n=40 Participants 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	Adapalene Gel With Eucerin n=39 Participants 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
Reduction of Undesirable Effects Erythema (none)	26 participants	38 participants	35 participants
Reduction of Undesirable Effects Erythema (mild)	10 participants	2 participants	4 participants
Reduction of Undesirable Effects Erythema (moderate)	3 participants	0 participants	0 participants
Reduction of Undesirable Effects Dryness (none)	21 participants	29 participants	32 participants
Reduction of Undesirable Effects Dryness (mild)	14 participants	11 participants	6 participants
Reduction of Undesirable Effects Dryness (moderate)	4 participants	0 participants	1 participants
Reduction of Undesirable Effects Scaling (none)	13 participants	16 participants	24 participants
Reduction of Undesirable Effects Scaling (mild)	22 participants	24 participants	14 participants
Reduction of Undesirable Effects Scaling (moderate)	4 participants	0 participants	1 participants
Reduction of Undesirable Effects Stinging (none)	6 participants	9 participants	6 participants
Reduction of Undesirable Effects Stinging (mild)	14 participants	12 participants	11 participants
Reduction of Undesirable Effects Stinging (moderate)	10 participants	13 participants	13 participants
Reduction of Undesirable Effects Stinging (severe)	9 participants	6 participants	9 participants
Reduction of Undesirable Effects Pruritus (none)	18 participants	21 participants	23 participants
Reduction of Undesirable Effects Pruritus (mild)	10 participants	8 participants	9 participants
Reduction of Undesirable Effects Pruritus (moderate)	7 participants	6 participants	5 participants
Reduction of Undesirable Effects Pruritus (severe)	4 participants	5 participants	2 participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Adapalene Gel n=39 Participants 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	Adapalene Gel With Placebo Moisturizer n=40 Participants 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	Adapalene Gel With Eucerin n=39 Participants 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
Skin Tolerability: Skin Sebum Content and Skin Hydration Baseline Sebumeter	75.7 µg/cm^2 Standard Deviation 34.4	71.2 µg/cm^2 Standard Deviation 42.4	73.7 µg/cm^2 Standard Deviation 31.2
Skin Tolerability: Skin Sebum Content and Skin Hydration Week 8 Sebumeter	63.6 µg/cm^2 Standard Deviation 31.7	59.9 µg/cm^2 Standard Deviation 55.3	64.2 µg/cm^2 Standard Deviation 35.0
Skin Tolerability: Skin Sebum Content and Skin Hydration Baseline Corneometer	51.7 µg/cm^2 Standard Deviation 10.0	50.2 µg/cm^2 Standard Deviation 10.5	46.7 µg/cm^2 Standard Deviation 11.3
Skin Tolerability: Skin Sebum Content and Skin Hydration Week 8 Corneometer	50.9 µg/cm^2 Standard Deviation 10.9	49.5 µg/cm^2 Standard Deviation 9.4	48.6 µg/cm^2 Standard Deviation 9.3

PRIMARY outcome

Timeframe: 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 was assessed by measuring TEWL with the Tewameter TM300

Outcome measures

Outcome measures
Measure	Adapalene Gel n=39 Participants 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	Adapalene Gel With Placebo Moisturizer n=40 Participants 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	Adapalene Gel With Eucerin n=39 Participants 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
Skin Tolerability: Transepidermal Water Loss (TEWL) Baseline TEWL	9.8 g/m^2h Standard Deviation 3.3	10.4 g/m^2h Standard Deviation 4.6	10.6 g/m^2h Standard Deviation 3.7
Skin Tolerability: Transepidermal Water Loss (TEWL) Week 8 TEWL	12.3 g/m^2h Standard Deviation 4.8	11.8 g/m^2h Standard Deviation 5.4	11.5 g/m^2h Standard Deviation 3.3

SECONDARY outcome

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

* 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

Outcome measures

Outcome measures
Measure	Adapalene Gel n=39 Participants 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	Adapalene Gel With Placebo Moisturizer n=40 Participants 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	Adapalene Gel With Eucerin n=39 Participants 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
Reduction of Severity of Acne Week 2 Inflammatory Lesion Counts	4.5 Lesions Standard Deviation 6.6	4.1 Lesions Standard Deviation 7.4	3.6 Lesions Standard Deviation 3.9
Reduction of Severity of Acne Week 4 Inflammatory Lesion Counts	3.6 Lesions Standard Deviation 5.4	2.9 Lesions Standard Deviation 2.9	3.4 Lesions Standard Deviation 3.5
Reduction of Severity of Acne Week 8 Inflammatory Lesion Counts	2.5 Lesions Standard Deviation 5.6	3.1 Lesions Standard Deviation 4.1	2.4 Lesions Standard Deviation 3.0
Reduction of Severity of Acne Baseline Noninflammatory Counts	32.4 Lesions Standard Deviation 48.0	24.5 Lesions Standard Deviation 37.3	21.6 Lesions Standard Deviation 16.2
Reduction of Severity of Acne Week 4 Noninflammatory Counts	35.4 Lesions Standard Deviation 50.6	24.4 Lesions Standard Deviation 24.4	22.6 Lesions Standard Deviation 16.1
Reduction of Severity of Acne Week 8 Noninflammatory Counts	26.4 Lesions Standard Deviation 29.1	23.7 Lesions Standard Deviation 20.1	17.7 Lesions Standard Deviation 14.7
Reduction of Severity of Acne Baseline Total Lesion Count	35.9 Lesions Standard Deviation 49.1	27.4 Lesions Standard Deviation 37.0	25.5 Lesions Standard Deviation 16.9
Reduction of Severity of Acne Week 2 Total Lesion Count	41 Lesions Standard Deviation 65.7	26.6 Lesions Standard Deviation 29.3	23.8 Lesions Standard Deviation 16.6
Reduction of Severity of Acne Week 4 Total Lesion Count	39 Lesions Standard Deviation 54.2	27.3 Lesions Standard Deviation 25.2	25.7 Lesions Standard Deviation 16.7
Reduction of Severity of Acne Week 8 Total Lesion Count	28.9 Lesions Standard Deviation 33.3	26.8 Lesions Standard Deviation 22.5	19.9 Lesions Standard Deviation 15.2
Reduction of Severity of Acne Baseline Inflammatory Lesion Counts	3.5 Lesions Standard Deviation 3.9	3 Lesions Standard Deviation 2.6	3.8 Lesions Standard Deviation 3.3
Reduction of Severity of Acne Week 2 Noninflammatory Counts	36.5 Lesions Standard Deviation 61.9	22.5 Lesions Standard Deviation 28.1	20.5 Lesions Standard Deviation 15.3

SECONDARY outcome

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

* 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

Outcome measures

Outcome measures
Measure	Adapalene Gel n=39 Participants 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	Adapalene Gel With Placebo Moisturizer n=40 Participants 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	Adapalene Gel With Eucerin n=39 Participants 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
Reduction of Severity of Acne: Acne Severity Index (ASI) Baseline ASI	11.7 units on a scale Standard Deviation 13.6	9.4 units on a scale Standard Deviation 9.5	9.5 units on a scale Standard Deviation 5.8
Reduction of Severity of Acne: Acne Severity Index (ASI) Week 2 ASI	14.4 units on a scale Standard Deviation 20.8	10.4 units on a scale Standard Deviation 11.3	8.7 units on a scale Standard Deviation 6.1
Reduction of Severity of Acne: Acne Severity Index (ASI) Week 4 ASI	13.6 units on a scale Standard Deviation 19.4	9.2 units on a scale Standard Deviation 7.5	9.2 units on a scale Standard Deviation 5.9
Reduction of Severity of Acne: Acne Severity Index (ASI) Week 8 ASI	9.5 units on a scale Standard Deviation 13.7	9.3 units on a scale Standard Deviation 8.5	7.1 units on a scale Standard Deviation 5.3

Adverse Events

Adapalene Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adapalene Gel With Placebo Moisturizer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adapalene Gel With Eucerin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Papapit Tuchinda

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Phone: +662-419-4333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place