A Phase 3 Study to Compare the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG) Twice Daily in Combination With Once Daily Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4%
NCT00151541 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301
Last updated 2011-05-30
Summary
The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel, (DTG) twice daily in combination with once daily vehicle control, adapalene gel 0.1% or benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.
Conditions
- Acne Vulgaris
Interventions
- DRUG
-
Dapsone Topical Gel + adapalene gel 0.1%
- DRUG
-
Dapsone Topical Gel + benzoyl peroxide gel 4%
- DRUG
-
Dapsone Topical Gel + vehicle control
Sponsors & Collaborators
-
Allergan
lead INDUSTRY
Principal Investigators
-
Steven Garrett, MS, DDS, FACS · QLT USA, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-02-28
- Primary Completion
- 2005-07-31
- Completion
- 2005-07-31
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