Epiduo Pediatric Acne Study

Galderma

Status and phase: Completed; Phase 4

Conditions: Acne

Treatments: Drug: Topical Gel Vehicle; Drug: adapalene/benzoyl peroxide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01138735

RD.06.SPR.18155

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

Enrollment: 285 patients

Sex: All

Ages: 9 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of acne vulgaris with facial involvement
• Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
• A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline

Exclusion criteria

• Acne nodule or acne cyst
• Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
• Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
• Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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285 participants in 2 patient groups, including a placebo group

adapalene/benzoyl peroxide

Active Comparator group

Description:

Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks

Treatment:

Drug: adapalene/benzoyl peroxide

Topical Gel Vehicle

Placebo Comparator group

Description:

Topical Gel Vehicle applied topically once daily for 12 weeks

Treatment:

Drug: Topical Gel Vehicle