Systemic and Topical Metformin Versus Glycolic Acid Peel for the Treatment of Acanthosis Nigricans (NCT07751549) | Clinical Trial Compass
CompletedNot Applicable
Systemic and Topical Metformin Versus Glycolic Acid Peel for the Treatment of Acanthosis Nigricans
Egypt54 participantsStarted 2023-06-03
Plain-language summary
Acanthosis nigricans (AN) is a common dermatologic condition associated with insulin resistance and obesity. Existing treatment options often provide inconsistent results. This randomized, single-blinded, parallel-group clinical trial was conducted to evaluate and compare the efficacy and safety of systemic metformin, topical metformin 30%, and 70% glycolic acid chemical peel in the treatment of patients with acanthosis nigricans.
Fifty-four patients with clinically diagnosed acanthosis nigricans were randomly assigned to receive oral metformin, topical metformin 30%, or glycolic acid 70% chemical peel. Clinical efficacy was assessed using the Acanthosis Nigricans Area and Severity Index (ANASI), Global Aesthetic Improvement Scale (GAIS), dermoscopic evaluation, patient satisfaction, and safety outcomes. The study aimed to determine whether topical metformin provides efficacy comparable to systemic metformin while reducing treatment-related adverse effects.
Who can participate
Age range
11 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 acanthosis nigricans. Age 11 years or older. Male or female participants. Willingness and ability to comply with the study protocol and provide written informed consent (or assent with parental/guardian consent for minors, as applicable).
Exclusion Criteria:
* Pregnancy or lactation. History of keloid formation or post-peel hyperpigmentation. Active skin infection. Malignant acanthosis nigricans. Use of other treatments for acanthosis nigricans within the previous 3 months.
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 Acanthosis Nigricans Area and Severity Index (ANASI) score