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

Almirall

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Dapsone Gel Vehicle; Drug: Dapsone Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01974323

225678-007

Details and patient eligibility

About

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

Full description

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.

Enrollment: 2,238 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,238 participants in 2 patient groups, including a placebo group

Dapsone Gel

Experimental group

Description:

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

Treatment:

Drug: Dapsone Gel

Dapsone Gel Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Dapsone Gel Vehicle