Overview

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

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Galderma Laboratories, L.P.
Treatments:
Adapalene
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.)