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

Phase 1
Completed
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
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.).

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
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
NameTimeMethod
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
NameTimeMethod
6 Question Subject Cosmetic Acceptability Questionnaireweek 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

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