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

NCT01406080 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-04-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Galderma Brasil Ltda.

    lead INDUSTRY

Principal Investigators

  • Ananda Quadros Campos · Galderma Brasil Lltda

  • Edileia Bagatin · Universidade Federal de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01406080 on ClinicalTrials.gov