NCT01406080

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

Single-blinded, Multicenter, Randomized, Comparative Study of Efficacy and Safety of Adapalene Gel 0.3% Versus Tretinoin Emollient Cream 0.05% in the Treatment of Cutaneous Photoaging.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Galderma Brasil Ltda. · Industry
• Sex: All
• Age: 35 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Photoaging
• Photodamage

Interventions

Type	Name	Description
DRUG	Adapalene	Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region.
DRUG	Tretinoin	Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-07-29
• Last updated: 2017-04-06

Locations

4 sites across 1 country: Brazil