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



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:12 - Any
Updated:10/10/2018
Start Date:November 2013
End Date:October 2014

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A Safety and Efficacy Study to Compare Dapsone Dermal Gel With Vehicle Control in Patients With Acne Vulgaris

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

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.

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
We found this trial at
2
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mi
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North Bay,
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Encino, CA
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