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Completed

NCT Number: NCT07751549

Systemic and Topical Metformin Versus Glycolic Acid Peel for the Treatment of Acanthosis Nigricans

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.

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Key information

Conditions

Acanthosis Nigricans Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

systemic metformin

Drug

systemic metformin

topical intervention

Drug

topical metformin cream

glycolic acid 70% peeling

Procedure

glycolic acid 70% peeling

Primary outcomes

  1. Change in Acanthosis Nigricans Area and Severity Index (ANASI) score

    Time frame: Baseline and 3 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Evaluation of the Efficacy and Safety of Systemic Metformin, Topical Metformin 30%, and Glycolic Acid 70% Chemical Peel in the Treatment of Patients With Acanthosis Nigricans: A Randomized Comparative Study

Acronym: MET-AN

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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