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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07751549
Acronym
MET-AN
Enrollment
54
Registered
2026-08-07
Start date
2023-06-03
Completion date
2026-05-25
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acanthosis Nigricans

Keywords

acanthosis nigricans, metformin, glycolic acid

Brief 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.

Interventions

DRUGsystemic metformin

systemic metformin

DRUGtopical intervention

topical metformin cream

PROCEDUREglycolic acid 70% peeling

glycolic acid 70% peeling

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in Acanthosis Nigricans Area and Severity Index (ANASI) scoreBaseline and 3 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026