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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Skin Manifestations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Differin® Cream 0.1%

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

Group Type ACTIVE_COMPARATOR

adapalene cream 0.1% and adapalene lotion 0.1%

Intervention Type DRUG

adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks

Differin® Lotion 0.1%

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

Group Type ACTIVE_COMPARATOR

adapalene lotion 0.1%

Intervention Type DRUG

adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks

Interventions

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adapalene cream 0.1% and adapalene lotion 0.1%

adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks

Intervention Type DRUG

adapalene lotion 0.1%

adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks

Intervention Type DRUG

Other Intervention Names

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Differin® Cream 0.1% Differin® Lotion 0.1%

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes