drugset / Trial / NCT00151541

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

Phase 3 Completed 301 enrolled Allergan
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2005-02
Primary completion
2005-07
Completion
2005-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Adapalene Other / unclassified 0.1 % Topical
Subject Benzoyl Peroxide Other / unclassified 4 % Topical
Subject Dapsone Small molecule 5 % Topical

Indications