Overview

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

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Almirall, S.A.
Collaborator:
Allergan
Treatments:
Dapsone
Criteria
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