Efficacy and Safety of a Combined Topical Formula Versus Placebo in Patients With Melasma (NCT07727954) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of a Combined Topical Formula Versus Placebo in Patients With Melasma
Mexico40 participantsStarted 2026-06-12
Plain-language summary
The goal of this clinical trial is to learn whether a topical formulation containing 12% azelaic acid and 5% tranexamic acid is effective and safe for treating melasma in adults. The main questions it aims to answer are:
Does the topical formulation reduce melasma severity compared with placebo after 4 weeks of treatment? Is the topical formulation safe and well tolerated?
Researchers will compare the active topical formulation with a placebo cream to determine whether the active treatment provides greater improvement in melasma severity and quality of life.
Participants will:
Be randomly assigned to receive either the active topical formulation or a placebo cream.
Apply the assigned treatment daily for 4 weeks. Attend scheduled clinical visits for assessment of melasma severity using the Melasma Area and Severity Index (MASI), quality of life using the Melasma Quality of Life Scale (MelasQoL), and standardized facial imaging with the VISIA® skin analysis system.
Be monitored for local adverse events throughout the study.
Who can participate
Age range
18 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.
Inclusion Criteria:
* Adults aged 18 to 60 years.
* Clinical diagnosis of facial melasma.
* Fitzpatrick skin phototypes II to V.
* Willing and able to comply with all study procedures and scheduled visits.
* Willing to use sunscreen throughout the study.
* Provided written informed consent.
Exclusion Criteria:
* Pregnancy or breastfeeding.
* Known hypersensitivity to azelaic acid, tranexamic acid, or any component of the study formulation.
* Use of topical or systemic treatment for melasma within the previous 3 months.
* Presence of facial skin diseases or active skin infections that could interfere with study assessments.
* Participation in another clinical trial during the study period.
* Any medical condition that, in the investigator's judgment, could interfere with study participation or evaluation of the outcomes.
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
Change in Melasma Area and Severity Index (MASI) score