Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Adapalene/Benzoyl Peroxide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00446043

RD.06.SPR.18089

Details and patient eligibility

About

This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.

Enrollment: 452 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A clinical diagnosis of acne vulgaris with facial involvement.
• A minimum of 20 but not more than 50 Inflammatory lesions.
• A minimum of 30 but not more than 100 Noninflammatory lesions.

Exclusion criteria

• Subjects with presence of nodules or cysts.
• Acne conglobate, acne fulminans, secondary acne, or severe acne.
• Underlying diseases that required the use of interfering topical or systemic therapy.
• Use of prohibited medications prior to the study unless appropriate washout period was documented.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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452 participants in 1 patient group

Adapalene/Benzoyl Peroxide

Experimental group

Description:

Participants were treated with adapalene 0.1 percent (%) \[weight by weight (W/W)\] and benzoyl peroxide 2.5 percent (%) (W/W) gel topically to the face and trunk area once daily in the evening.

Treatment:

Drug: Adapalene/Benzoyl Peroxide