A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

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Detailed Description

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This is a multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to assess the safety and efficacy of dapsone 7.5% gel versus vehicle administered topically once daily for 12 weeks in patients with acne vulgaris.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dapsone Gel

Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Group Type EXPERIMENTAL

Dapsone Gel

Intervention Type DRUG

Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Dapsone Gel Vehicle

Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Group Type PLACEBO_COMPARATOR

Dapsone Gel Vehicle

Intervention Type DRUG

Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Interventions

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Dapsone Gel

Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Intervention Type DRUG

Dapsone Gel Vehicle

Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of acne vulgaris
* Willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study

Exclusion Criteria

* Severe cystic acne, acne conglobata, acne fulminans, or secondary acne
* Use of phototherapy devices (eg, ClearLight™), energy-based devices, adhesive cleansing strips (eg, Pond's®, Biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week
* Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products \[eg, benzamycin\]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks
* Use of birth control pills strictly for acne control

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No