Acne
Conditions
Keywords
Acne, Moisturizer, Efficacy, Irritation
Brief summary
Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory property could reduce irritant effects, emergent from using topical treatment and also reduce severity of acne. Research teams chose an adapalene gel to act as topical treatment for curing acne. It has anti-inflammatory and comedolytic effects and has fewer side effects than other groups of topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching sensation may occur if they are continually used for a long period. Thus, for the purpose of studying the efficacy of moisturizer containing licochalcone A, L-carnitine and 1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has anti-bacterial effect).
Detailed description
The investigators team research with patients by separate patients into 3 groups and compare among each other. In the first group use only adapalene gel, the second group use adapalene gel with moisturizer containing three substances mentioned above, and the last group use adapalene gel with placebo moisturizer. To compare outcomes among 3 groups, the investigators will measure degree of redness, scale, oily face, moist, number of acne, quality of life, and satisfaction after using moisturizer.
Interventions
OTHERAdapalene gel
Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
OTHERAdapalene 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
OTHERAdapalene 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
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years old or above 2. Participants have to control the birth for example, condom method, intrauterine device method before participate in the research at least 1 month until 6 months after research finish. 3. being diagnosed acne vulgaris by dermatologist in mild to moderate degree based on Investigators' Global Assessment scale of FDA
Exclusion criteria
1. Use oral or injected antibiotics or other oral medicine treating acne for example, isotretinoin, oral contraceptives, or spironolactone group during 4 weeks before participate this research 2. Have other active skin diseases at face during 2 weeks before participate the research 3. Allergic to adapalene gel and moisturizer 4. Have severe or uncontrolled underlying diseases 5. Getting pregnant or during breast feeding 6. Other types of acne(not acne vulgaris)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Undesirable Effects | 2nd week, 4th week, and 8th week | * 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. |
| Skin Tolerability: Skin Sebum Content and Skin Hydration | 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 |
| Skin Tolerability: Transepidermal Water Loss (TEWL) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Severity of Acne | 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 |
| Reduction of Severity of Acne: Acne Severity Index (ASI) | 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 |
Countries
Thailand
Participant flow
Recruitment details
The recruitment period: between June 2014 and December 2014 Location: Department of Dermatology, Siriraj Hospital, Mahidol University, Thailand
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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 | 40 |
| 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 | 40 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | lack of compliance | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Adapalene Gel | Adapalene Gel With Placebo Moisturizer | Adapalene Gel With Eucerin | Total |
|---|---|---|---|---|
| Age, Continuous | 27.3 years | 27.2 years | 28.1 years | 27.5 years |
| Gender Female | 22 Participants | 19 Participants | 26 Participants | 67 Participants |
| Gender Male | 18 Participants | 21 Participants | 14 Participants | 53 Participants |
| Region of Enrollment Thailand | 40 participants | 40 participants | 40 participants | 120 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
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.
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adapalene Gel | Reduction of Undesirable Effects | Pruritus (moderate) | 7 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Erythema (none) | 26 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Pruritus (mild) | 10 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Stinging (mild) | 14 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Erythema (mild) | 10 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Pruritus (none) | 18 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Scaling (moderate) | 4 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Erythema (moderate) | 3 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Stinging (none) | 6 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Scaling (mild) | 22 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Dryness (moderate) | 4 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Stinging (severe) | 9 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Pruritus (severe) | 4 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Scaling (none) | 13 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Stinging (moderate) | 10 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Dryness (none) | 21 participants |
| Adapalene Gel | Reduction of Undesirable Effects | Dryness (mild) | 14 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Stinging (mild) | 12 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Dryness (none) | 29 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Scaling (none) | 16 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Stinging (none) | 9 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Stinging (severe) | 6 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Pruritus (moderate) | 6 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Pruritus (severe) | 5 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Dryness (mild) | 11 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Erythema (none) | 38 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Erythema (mild) | 2 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Erythema (moderate) | 0 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Dryness (moderate) | 0 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Scaling (mild) | 24 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Scaling (moderate) | 0 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Stinging (moderate) | 13 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Pruritus (none) | 21 participants |
| Adapalene Gel With Placebo Moisturizer | Reduction of Undesirable Effects | Pruritus (mild) | 8 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Pruritus (severe) | 2 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Scaling (moderate) | 1 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Stinging (none) | 6 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Erythema (none) | 35 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Dryness (none) | 32 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Stinging (mild) | 11 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Erythema (moderate) | 0 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Pruritus (mild) | 9 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Stinging (moderate) | 13 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Pruritus (moderate) | 5 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Scaling (none) | 24 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Pruritus (none) | 23 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Dryness (moderate) | 1 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Dryness (mild) | 6 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Stinging (severe) | 9 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Scaling (mild) | 14 participants |
| Adapalene Gel With Eucerin | Reduction of Undesirable Effects | Erythema (mild) | 4 participants |
p-value: 0.001Kruskal-Wallis
p-value: 0.016Kruskal-Wallis
p-value: 0.025Kruskal-Wallis
p-value: 0.571Kruskal-Wallis
p-value: 0.449Kruskal-Wallis
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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene Gel | Skin Tolerability: Skin Sebum Content and Skin Hydration | Week 8 Corneometer | 50.9 µg/cm^2 | Standard Deviation 10.9 |
| Adapalene Gel | Skin Tolerability: Skin Sebum Content and Skin Hydration | Baseline Sebumeter | 75.7 µg/cm^2 | Standard Deviation 34.4 |
| Adapalene Gel | Skin Tolerability: Skin Sebum Content and Skin Hydration | Week 8 Sebumeter | 63.6 µg/cm^2 | Standard Deviation 31.7 |
| Adapalene Gel | Skin Tolerability: Skin Sebum Content and Skin Hydration | Baseline Corneometer | 51.7 µg/cm^2 | Standard Deviation 10 |
| Adapalene Gel With Placebo Moisturizer | Skin Tolerability: Skin Sebum Content and Skin Hydration | Baseline Corneometer | 50.2 µg/cm^2 | Standard Deviation 10.5 |
| Adapalene Gel With Placebo Moisturizer | Skin Tolerability: Skin Sebum Content and Skin Hydration | Week 8 Corneometer | 49.5 µg/cm^2 | Standard Deviation 9.4 |
| Adapalene Gel With Placebo Moisturizer | Skin Tolerability: Skin Sebum Content and Skin Hydration | Week 8 Sebumeter | 59.9 µg/cm^2 | Standard Deviation 55.3 |
| Adapalene Gel With Placebo Moisturizer | Skin Tolerability: Skin Sebum Content and Skin Hydration | Baseline Sebumeter | 71.2 µg/cm^2 | Standard Deviation 42.4 |
| Adapalene Gel With Eucerin | Skin Tolerability: Skin Sebum Content and Skin Hydration | Baseline Corneometer | 46.7 µg/cm^2 | Standard Deviation 11.3 |
| Adapalene Gel With Eucerin | Skin Tolerability: Skin Sebum Content and Skin Hydration | Baseline Sebumeter | 73.7 µg/cm^2 | Standard Deviation 31.2 |
| Adapalene Gel With Eucerin | Skin Tolerability: Skin Sebum Content and Skin Hydration | Week 8 Sebumeter | 64.2 µg/cm^2 | Standard Deviation 35 |
| Adapalene Gel With Eucerin | Skin Tolerability: Skin Sebum Content and Skin Hydration | Week 8 Corneometer | 48.6 µg/cm^2 | Standard Deviation 9.3 |
p-value: 0.167Paired t-test
p-value: 0.078Paired t-test
p-value: 0.134Paired t-test
p-value: 0.978Paired t-test
p-value: 0.273Paired t-test
p-value: 0.735Paired t-test
Primary
Skin Tolerability: Transepidermal Water Loss (TEWL)
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene Gel | Skin Tolerability: Transepidermal Water Loss (TEWL) | Baseline TEWL | 9.8 g/m^2h | Standard Deviation 3.3 |
| Adapalene Gel | Skin Tolerability: Transepidermal Water Loss (TEWL) | Week 8 TEWL | 12.3 g/m^2h | Standard Deviation 4.8 |
| Adapalene Gel With Placebo Moisturizer | Skin Tolerability: Transepidermal Water Loss (TEWL) | Baseline TEWL | 10.4 g/m^2h | Standard Deviation 4.6 |
| Adapalene Gel With Placebo Moisturizer | Skin Tolerability: Transepidermal Water Loss (TEWL) | Week 8 TEWL | 11.8 g/m^2h | Standard Deviation 5.4 |
| Adapalene Gel With Eucerin | Skin Tolerability: Transepidermal Water Loss (TEWL) | Baseline TEWL | 10.6 g/m^2h | Standard Deviation 3.7 |
| Adapalene Gel With Eucerin | Skin Tolerability: Transepidermal Water Loss (TEWL) | Week 8 TEWL | 11.5 g/m^2h | Standard Deviation 3.3 |
p-value: 0.0002Paired t-test
p-value: 0.007Paired t-test
p-value: 0.123Paired t-test
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
Time frame: baseline, 2nd week, 4th week and 8th week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene Gel | Reduction of Severity of Acne | Baseline Total Lesion Count | 35.9 Lesions | Standard Deviation 49.1 |
| Adapalene Gel | Reduction of Severity of Acne | Week 2 Total Lesion Count | 41 Lesions | Standard Deviation 65.7 |
| Adapalene Gel | Reduction of Severity of Acne | Week 4 Total Lesion Count | 39 Lesions | Standard Deviation 54.2 |
| Adapalene Gel | Reduction of Severity of Acne | Week 8 Total Lesion Count | 28.9 Lesions | Standard Deviation 33.3 |
| Adapalene Gel | Reduction of Severity of Acne | Baseline Inflammatory Lesion Counts | 3.5 Lesions | Standard Deviation 3.9 |
| Adapalene Gel | Reduction of Severity of Acne | Week 2 Inflammatory Lesion Counts | 4.5 Lesions | Standard Deviation 6.6 |
| Adapalene Gel | Reduction of Severity of Acne | Week 4 Inflammatory Lesion Counts | 3.6 Lesions | Standard Deviation 5.4 |
| Adapalene Gel | Reduction of Severity of Acne | Week 8 Inflammatory Lesion Counts | 2.5 Lesions | Standard Deviation 5.6 |
| Adapalene Gel | Reduction of Severity of Acne | Baseline Noninflammatory Counts | 32.4 Lesions | Standard Deviation 48 |
| Adapalene Gel | Reduction of Severity of Acne | Week 2 Noninflammatory Counts | 36.5 Lesions | Standard Deviation 61.9 |
| Adapalene Gel | Reduction of Severity of Acne | Week 4 Noninflammatory Counts | 35.4 Lesions | Standard Deviation 50.6 |
| Adapalene Gel | Reduction of Severity of Acne | Week 8 Noninflammatory Counts | 26.4 Lesions | Standard Deviation 29.1 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Baseline Inflammatory Lesion Counts | 3 Lesions | Standard Deviation 2.6 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Baseline Total Lesion Count | 27.4 Lesions | Standard Deviation 37 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Week 8 Noninflammatory Counts | 23.7 Lesions | Standard Deviation 20.1 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Baseline Noninflammatory Counts | 24.5 Lesions | Standard Deviation 37.3 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Week 4 Inflammatory Lesion Counts | 2.9 Lesions | Standard Deviation 2.9 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Week 2 Total Lesion Count | 26.6 Lesions | Standard Deviation 29.3 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Week 2 Noninflammatory Counts | 22.5 Lesions | Standard Deviation 28.1 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Week 4 Noninflammatory Counts | 24.4 Lesions | Standard Deviation 24.4 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Week 4 Total Lesion Count | 27.3 Lesions | Standard Deviation 25.2 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Week 8 Inflammatory Lesion Counts | 3.1 Lesions | Standard Deviation 4.1 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Week 2 Inflammatory Lesion Counts | 4.1 Lesions | Standard Deviation 7.4 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne | Week 8 Total Lesion Count | 26.8 Lesions | Standard Deviation 22.5 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Week 4 Noninflammatory Counts | 22.6 Lesions | Standard Deviation 16.1 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Week 2 Noninflammatory Counts | 20.5 Lesions | Standard Deviation 15.3 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Week 2 Inflammatory Lesion Counts | 3.6 Lesions | Standard Deviation 3.9 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Week 4 Inflammatory Lesion Counts | 3.4 Lesions | Standard Deviation 3.5 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Week 8 Inflammatory Lesion Counts | 2.4 Lesions | Standard Deviation 3 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Week 8 Total Lesion Count | 19.9 Lesions | Standard Deviation 15.2 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Baseline Total Lesion Count | 25.5 Lesions | Standard Deviation 16.9 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Baseline Inflammatory Lesion Counts | 3.8 Lesions | Standard Deviation 3.3 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Week 2 Total Lesion Count | 23.8 Lesions | Standard Deviation 16.6 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Baseline Noninflammatory Counts | 21.6 Lesions | Standard Deviation 16.2 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Week 4 Total Lesion Count | 25.7 Lesions | Standard Deviation 16.7 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne | Week 8 Noninflammatory Counts | 17.7 Lesions | Standard Deviation 14.7 |
p-value: 0.059wilcoxan signed ranks test
p-value: 0.697wilcoxan signed ranks test
p-value: 0.028wilcoxan signed ranks test
p-value: 0.001wilcoxan signed ranks test
p-value: 0.755wilcoxan signed ranks test
p-value: 0.003wilcoxan signed ranks test
p-value: 0.205wilcoxan signed ranks test
p-value: 0.576wilcoxan signed ranks test
p-value: 0.16wilcoxan signed ranks 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
Time frame: baseline, 2nd week, 4th week and 8th week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene Gel | Reduction of Severity of Acne: Acne Severity Index (ASI) | Week 8 ASI | 9.5 units on a scale | Standard Deviation 13.7 |
| Adapalene Gel | Reduction of Severity of Acne: Acne Severity Index (ASI) | Baseline ASI | 11.7 units on a scale | Standard Deviation 13.6 |
| Adapalene Gel | Reduction of Severity of Acne: Acne Severity Index (ASI) | Week 2 ASI | 14.4 units on a scale | Standard Deviation 20.8 |
| Adapalene Gel | Reduction of Severity of Acne: Acne Severity Index (ASI) | Week 4 ASI | 13.6 units on a scale | Standard Deviation 19.4 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne: Acne Severity Index (ASI) | Week 4 ASI | 9.2 units on a scale | Standard Deviation 7.5 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne: Acne Severity Index (ASI) | Week 8 ASI | 9.3 units on a scale | Standard Deviation 8.5 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne: Acne Severity Index (ASI) | Week 2 ASI | 10.4 units on a scale | Standard Deviation 11.3 |
| Adapalene Gel With Placebo Moisturizer | Reduction of Severity of Acne: Acne Severity Index (ASI) | Baseline ASI | 9.4 units on a scale | Standard Deviation 9.5 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne: Acne Severity Index (ASI) | Week 4 ASI | 9.2 units on a scale | Standard Deviation 5.9 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne: Acne Severity Index (ASI) | Baseline ASI | 9.5 units on a scale | Standard Deviation 5.8 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne: Acne Severity Index (ASI) | Week 2 ASI | 8.7 units on a scale | Standard Deviation 6.1 |
| Adapalene Gel With Eucerin | Reduction of Severity of Acne: Acne Severity Index (ASI) | Week 8 ASI | 7.1 units on a scale | Standard Deviation 5.3 |
p-value: 0.005wilcoxan signed ranks test
p-value: 0.606wilcoxan signed ranks test
p-value: 0.001wilcoxan signed ranks test