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

Galderma

Status and phase: Completed; Phase 1

Conditions: Skin Manifestations

Treatments: Drug: adapalene lotion 0.1%; Drug: adapalene cream 0.1% and adapalene lotion 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01046396

US10149

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 2 patient groups

Differin® Cream 0.1%

Active Comparator group

Description:

Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks

Treatment:

Drug: adapalene cream 0.1% and adapalene lotion 0.1%

Differin® Lotion 0.1%

Active Comparator group

Description:

Adapalene Lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks

Treatment:

Drug: adapalene lotion 0.1%