Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

Study Overview
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Brief Summary
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The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1% to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.

Official Title
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Split-Face Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

Conditions
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Skin Manifestations

Intervention / Treatment
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* Drug: adapalene cream 0.1% and adapalene lotion 0.1%
* Drug: adapalene lotion 0.1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged 18 years and older Subjects with healthy skin as determined by the clinical grader Exclusion Criteria: Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions. Subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study. Subjects with known allergy to one of the components of the study drugs (refer to the package insert for Differin® Cream 0.1% and the investigator's brochure for Differin® Lotion 0.1%). Subjects who have participated in another investigational drug or device research study within 30 days of enrollment. Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids. Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids. Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated. Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Differin® Cream 0.1%<br>Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks | Drug: adapalene cream 0.1% and adapalene lotion 0.1%<br>* adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks<br>* Other names: Differin® Cream 0.1%;|
| Active Comparator: Differin® Lotion 0.1%<br>Adapalene Lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks | Drug: adapalene lotion 0.1%<br>* adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks<br>* Other names: Differin® Lotion 0.1%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3. | Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each category of the tolerability assessments from baseline to week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success for each category was defined as a tolerability score of 0. | baseline to week 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 | Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) of each question of the Subject Cosmetic Acceptability Questionnaire at week 3. | week 3 |