CompletedPhase 2

Efficacy of Eflornithine Hydrochloride Cream in the Treatment of Melasma: A Randomized, Double-blinded, Split-face Controlled Study

Singapore20 participantsStarted 2023-06-06

Plain-language summary

The goal of this clinical trial is to learn if Eflornithine hydrochloride cream works to treat melasma in adults, in comparison to Hydroquinone cream. It will also learn about the safety of Eflornithine hydrochloride cream. The main questions it aims to answer are: * Does Eflornithine hydrochloride improve melasma assessment scores over a 3-month duration compared to Hydroquinone cream? * What side effects might patients get while using Eflornithine hydrochloride cream? Participants will: * Apply both Eflornithine hydrochloride and Hydroquinone creams on separate halves of their faces every day for 3 months. * Visit the clinic once at the 2-month mark and once at the 3-month mark for checkups and tests.

Who can participate

Age range

25 Years – 70 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: * Clinical diagnosis of melasma * Fitzpatrick Type III or IV * Able to provide informed consent Exclusion Criteria: * Pregnant or lactating patients * Patients with difficulty adhering to regular topical treatments * Patients with known contact allergies to any of the ingredients in the topical medications used in the study

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

Modified Melasma Area and Severity Index (mMASI)

Timeframe: At 8 weeks and 12 weeks

Mexameter melanin score

Timeframe: At 8 and 12 weeks

Trial details

NCT IDNCT06957834

SponsorNational Skin Centre

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-07-11

View on ClinicalTrials.gov More Melasma trials