Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
- Conditions
- Skin Manifestations
- Interventions
- Registration Number
- NCT01046565
- Lead Sponsor
- Galderma R&D
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Males or females aged 18 years and older
- Subjects with healthy skin as determined by the clinical grader.
- 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.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Differin® Lotion 0.1% adapalene lotion 0.1% adapalene lotion 0.1% - apply once daily on the opposite side of the face Differin® Cream 0.1% adapalene cream 0.1% Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method 6 Question Subject Cosmetic Acceptability Questionnaire week 3 Number of participants in each category (Differin® Lotion, Differin® Cream or No Preference) for each question of the Subject Cosmetic Acceptability Questionnaire at week 3.
Trial Locations
- Locations (1)
Thomas J. Stephens & Associates, Inc.
🇺🇸Carrollton, Texas, United States