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%
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.
Drug: Dapsone Topical Gel + adapalene gel 0.1%
Drug: Dapsone Topical Gel + benzoyl peroxide gel 4%
Drug: Dapsone Topical Gel + vehicle control
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 3, Randomized, Double-blind, Multi-dose Study to Evaluate the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG 5%) When Co-administered With Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4% in the Treatment of Acne Vulgaris.|
- The primary efficacy endpoint will be mean percent reduction in inflammatory lesion counts.
- Additional efficacy endpoints will be the mean percent reduction from Baseline in non-inflammatory and total lesion counts, as well as the proportion of subjects who achieve success (none/minimal) on a 5-point Global Acne Assessment Score.
- Safety endpoints will include treatment-emergent and treatment related adverse events. An additional safety endpoint will be the local adverse reaction assessment.
|Study Start Date:||February 2005|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
This is a 3 arm, 12-week, randomized, double-blind, multicenter study comparing safety and efficacy of DTG 5% twice daily plus vehicle control once daily vs. DTG 5% twice daily plus adapalene gel 0.1% once daily vs. DTG 5% twice daily plus 4% benzoyl peroxide gel once daily in subjects with acne vulgaris. Approximately 300 male and female subjects, 12 years of age and older, with acne vulgaris and > 20 inflammatory lesions (papules and/or pustules) and > 20 non-inflammatory lesions (comedones) above the mandibular line at Baseline will be enrolled. Follow-up visits will occur at Week 2, 4, 8 and 12. Global Acne Assessments, Lesion Counts and Local Adverse Reaction Assessments will be conducted at each visit. A physical exam will be done at Baseline and Week 12. Plasma Dapsone Level samples will be drawn at Baseline, Week 2 and Week 12/ET for dapsone plasma level assessments. Adverse events and concomitant medications will be assessed throughout the study.