Azelaic Acid 20% vs Hydroquinone 4% in Epidermal Melasma (NCT07327983) | Clinical Trial Compass
CompletedNot Applicable
Azelaic Acid 20% vs Hydroquinone 4% in Epidermal Melasma
Pakistan146 participantsStarted 2025-05-04
Plain-language summary
Melasma is a common skin condition that causes dark patches on the face and can significantly affect quality of life. This study compared two commonly used topical treatments, 20% azelaic acid and 4% hydroquinone, in adults with epidermal melasma.
Participants with epidermal melasma were randomly assigned to receive either azelaic acid 20% or hydroquinone 4% for a period of 12 weeks. The severity of melasma was assessed at baseline and monthly using the Melasma Area and Severity Index (MASI) score. Side effects such as irritation, redness, burning, itching, and dryness were also monitored throughout the study.
The purpose of this study was to compare the effectiveness and safety of azelaic acid and hydroquinone in reducing melasma severity and to determine whether azelaic acid can be used as a safe alternative to hydroquinone.
Who can participate
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:
* Patients with clinically diagnosed epidermal melasma confirmed by Wood's lamp examination
* Male or female participants of any age
* Willingness to provide written informed consent
* Ability to comply with study procedures and follow-up visits
Exclusion Criteria:- Dermal or mixed-type melasma
* Active cutaneous or facial skin infection
* History of keloid formation
* Recent use of other topical or systemic depigmenting agents
* Presence of photosensitive disorders
* Pregnancy or lactation
* Refusal or inability to provide written informed consent
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
Timeframe: Baseline to 12 weeks
Trial details
NCT IDNCT07327983
SponsorGujranwala medical college District Headquarters Hospital, Gujranwala