ClinicalTrials.gg
CompletedNCT07751549MET-ANUpdated Aug 7, 2026

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

An interventional study of systemic metformin and topical intervention in Acanthosis Nigricans, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 11 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Jun 2023, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
11 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acanthosis Nigricans

Keywords

  • acanthosis nigricans
  • metformin
  • glycolic acid
03

In context

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (or assent with parental/guardian consent for minors, as applicable).

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    systemic metformin

    Drug: systemic metformin

  • Active comparator
    topical metformin

    Drug: topical intervention

  • Active comparator
    glycolic acid

    Procedure: glycolic acid 70% peeling

Interventions

  • Drugsystemic metformin

    systemic metformin

  • Drugtopical intervention

    topical metformin cream

  • Procedureglycolic acid 70% peeling

    glycolic acid 70% peeling

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline and 3 months

07

Study locations

1 site
  • Tanta University Hospitals
    Tanta, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Jul 2025, 25 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2026
First posted
Aug 7, 2026
StartActual
Jun 3, 2023
Primary completionActual
Jul 13, 2025
CompletionActual
May 25, 2026
Last update
Aug 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07751549
Lead sponsor
Tanta University
Responsible party
Nesrin Sabry (Lecturer at Dermatology and Venereology, Tanta University) — Principal investigator
First posted
Aug 7, 2026
Start date
Jun 3, 2023
Primary completion
Jul 13, 2025
Completion
May 25, 2026
Last update
Aug 7, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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