A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin

A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin

A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin
Emollient Cream, 0.05% for the Treatment of Photoaging
Status: Recruiting
Study Phase: Phase 3
Start Date: January 2013 | Completion Date: November 2013
Condition(s): Photoaging, Photodamage
Full Title of Study
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.
Overview
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.
Study Details
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary
Purpose: Treatment
Investigator Details
Lead Sponsor: Galderma Brasil Ltda.
Study Director: Alessandra Nogueira Galderma Brasil Lltda
Principal Investigator: Edileia Bagatin Universidade Federal de São Paulo
Trial Location Details
Facility: Centro de Dermatologia Dona Libania Fortaleza, Brazil
Principal Investigator: Heitor de Sá Gonçalves
Sub-Investigator: Maria Araci Pontes Aires
Facility: Santa Casa de Belo Horizonte Belo Horizonte, Brazil
Facility: Hospital de Clínicas da Universidade Federal do Paraná Curitiba, Brazil
Principal Investigator: Mauricio Shigueru Sato
Facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre Porto Alegre, Brazil
Facility: Universidade Federal de São Paulo - UNIFESP - UNICCO São Paulo, Brazil
Principal Investigator: Ediléia Bagatin
Sub-Investigator: Karime Hassun
Sub-Investigator: Sonia Lopes Beta Yamada
Facility: Hospital das Clínicas da FMUSP São Paulo, Brazil
Interventions
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.
Information Source
ID Number: BR.10.002
NCT Identifier: NCT01406080
by this site. Please see the full source link above for retrieving further details from the government database.