Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-08-31

Brief Summary

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This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

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Detailed Description

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Same as above.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Treatment

adapalene gel, 0.3%

Other Names:

Differin® Gel, 0.3% Applied once daily at bedtime

clindamycin/benzoyl peroxide gel

Other Names:

Duac® Gel Applied once daily in the morning

Group Type EXPERIMENTAL

adapalene gel, 0.3%

Intervention Type DRUG

Applied once daily at bedtime

clindamycin/benzoyl peroxide gel

Intervention Type DRUG

Applied once daily in the morning

Interventions

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adapalene gel, 0.3%

Applied once daily at bedtime

Intervention Type DRUG

clindamycin/benzoyl peroxide gel

Applied once daily in the morning

Intervention Type DRUG

Other Intervention Names

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Differin® Gel, 0.3% Duac® Gel

Eligibility Criteria

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Inclusion Criteria

1. Subjects with a minimum of 20 inflammatory lesions on the face;
2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
3. Subject has a Global Severity Assessment