A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Galderma

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Benzoyl Peroxide; Drug: Topical Gel Vehicle; Drug: Adapalene; Drug: Adapalene/Benzoyl Peroxide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00421993

RD.06.SPR.18088

Details and patient eligibility

About

This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.

The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Enrollment: 1,670 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
• A score of 3 (Moderate) on the Investigator's Global Assessment Scale.

Exclusion criteria

• More than one acne nodule or any acne cyst.
• Acne conglobata, acne fulminans, secondary acne, or severe acne.
• Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
• Underlying diseases that require the use of interfering topical or systemic therapy.
• Use of prohibited medications prior to the study unless appropriate washout period is documented
• Use of hormonal contraceptives solely for control of acne

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,670 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Adapalene/Benzoyl Peroxide Topical Gel

Treatment:

Drug: Adapalene/Benzoyl Peroxide

2

Active Comparator group

Description:

Adapalene Topical Gel

Treatment:

Drug: Adapalene

3

Active Comparator group

Description:

Benzoyl Peroxide Topical Gel

Treatment:

Drug: Benzoyl Peroxide

4

Placebo Comparator group

Description:

Topical Gel Vehicle

Treatment:

Drug: Topical Gel Vehicle