Phase 1
Completed N=69
Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
Skin Manifestations
Source: ClinicalTrials.gov NCT01046396 ↗
Enrolled (actual)
69
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: 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. — 9; 9; 32; 30 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
9; 9; 32; 30; 14; 14 | — |
| SECONDARY 6 Question Subject Cosmetic Acceptability Questionnaire at Week 3 |
19; 12; 33; 27; 17; 20 | — |
Eligibility Criteria
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.)
Data sourced from ClinicalTrials.gov (NCT01046396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.