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%
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|ClinicalTrials.gov Identifier: NCT00151541|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : May 30, 2011
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Dapsone Topical Gel + adapalene gel 0.1% Drug: Dapsone Topical Gel + benzoyl peroxide gel 4% Drug: Dapsone Topical Gel + vehicle control||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||301 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151541
|Study Director:||Steven Garrett, MS, DDS, FACS||QLT USA, Inc.|