drugset / Trial / NCT01406080

A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging

NCT01406080

Phase 3 Completed 128 enrolled Galderma Brasil Ltda.
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to: 1. Evaluate the efficacy of Adapalene gel 0.3% compared to Tretinoin Emollient cream 0.05%, reducing signs of cutaneous photoageing, measured trough photonumeric scale evaluation, investigator evaluation of global response to treatment and subject's evaluation of improvement. 2. Evaluate the safety and tolerability of Adapalene Gel 0.3%, compared to Tretinoin Emollient cream 0.05% during 24 weeks of treatment. The study has the clinical hypothesis that Adapalene Gel 0.3% is as effective as Tretinoin Emollient cream 0.05% in the treatment of cutaneous photoaging.

Timeline

Start
2013-01
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adapalene Other / unclassified 0.3 % Topical
Comparator Tretinoin Small molecule 0.05 % Topical