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

Galderma

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: adapalene gel, 0.3%; Drug: clindamycin/benzoyl peroxide gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00671749

US10066

Details and patient eligibility

About

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.

Full description

Same as above.

Enrollment: 100 patients

Sex: All

Ages: 12 to 35 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

1. Subjects with more than three nodulo-cystic lesions

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Study Treatment

Experimental group

Description:

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

Treatment:

Drug: clindamycin/benzoyl peroxide gel

Drug: adapalene gel, 0.3%