A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatme… (NCT01406080) | Clinical Trial Compass
CompletedPhase 3
A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging
Brazil128 participantsStarted 2013-01
Plain-language 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.
Who can participate
Age range
35 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Individuals with other facial skin disorders or dermatosis (scars, inflammatory acne, etc.) that can interfere with the clinical evaluation;
. Patients with a history of treatment for photoaging using ablative laser technologies (such as carbon dioxide and Erbium: YAG) and / or non-ablative (Nd: YAG, Fractionated Erbium Glass, Diode, Infrared Light, Intense Pulsed Light, Radiofrequency, Pulsed Dye Laser), dermabrasion, medium or deep chemical peeling on face;
. Individuals diagnosed with skin cancer (squamous cell carcinoma, melanoma) in the last 3 months prior to study entry;
. Individuals not willing to refrain from any cosmetic procedure during the study period (e.g. other types of chemical peelings, microdermabrasion, etc.);
. Individuals with significant medical history, concomitant disease or condition in which the investigator believes that participation in the study is not propitious;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessing the extent of Cutaneous Photoaging at the end of treatment.