Acanthosis NigricansMET-ANNCT07751549
Systemic and Topical Metformin Versus Glycolic Acid Peel for the Treatment of Acanthosis Nigricans
A study testing systemic metformin, topical intervention and glycolic acid 70% peeling in people with Acanthosis Nigricans, run by Tanta University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Acanthosis Nigricans
- What is being tested?
- systemic metformin, topical intervention and glycolic acid 70% peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jun 2023to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Acanthosis Nigricans
- Being tested
- systemic metformin, topical intervention, glycolic acid 70% peeling
- Keywords
- acanthosis nigricans, metformin, glycolic acid
- Medical subject headings
- Acanthosis Nigricans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systemic metforminDrug
systemic metformin
topical interventionDrug
topical metformin cream
glycolic acid 70% peelingProcedure or surgery
glycolic acid 70% peeling
| Study group | Role | What they receive |
|---|---|---|
| systemic metformin | Active comparator | Not described Receives: Drug: systemic metformin |
| topical metformin | Active comparator | Not described Receives: Drug: topical intervention |
| glycolic acid | Active comparator | Not described Receives: Procedure: glycolic acid 70% peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Acanthosis Nigricans Area and Severity Index (ANASI) score
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start3 Jun 2023
- Primary completion13 Jul 2025
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acanthosis NigricansStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesrin Sabry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751549
- Sponsor's protocol ID
- 36264MS162/4/23
- Acronym
- MET-AN
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07751549
- Acronym / sponsor ID
- MET-AN / 36264MS162/4/23
- Conditions
- Acanthosis Nigricans
- Keywords
- acanthosis nigricans, metformin, glycolic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 13 Jul 2025 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| systemic metformin | Active comparator | Drug: systemic metformin |
| topical metformin | Active comparator | Drug: topical intervention |
| glycolic acid | Active comparator | Procedure: glycolic acid 70% peeling |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systemic metforminsystemic metformin | Drug | systemic metformin |
| topical interventiontopical metformin cream | Drug | topical metformin |
| glycolic acid 70% peelingglycolic acid 70% peeling | Procedure or surgery | glycolic acid |
Primary outcome
Change in Acanthosis Nigricans Area and Severity Index (ANASI) score
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Acanthosis Nigricans
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Active, not recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systemic metformin, topical intervention and glycolic acid 70% peeling in people with Acanthosis Nigricans, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acanthosis Nigricans Area and Severity Index (ANASI) score (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.