ClinicalTrials.gg
Not yet recruitingNCT07760181Updated Aug 12, 2026

Efficacy and Safety Of Fractional Carbon Dioxide Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans

A Phase 1 interventional study of Topical metformin in Acanthosis Nigricans, sponsored by Al-Azhar University. Not yet recruiting. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Al-Azhar University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

evaluate and compare the clinical Efficacy \& Safety Of Fractional Carbon Dioxide (Co₂) Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans.

Read the detailed description

combining fractional CO₂ laser with topical metformin may provide a synergistic therapeutic effect. This study aims to evaluate and compare the efficacy and safety of fractional CO₂ laser combined with topical metformin versus fractional CO₂ laser using a split-neck design

02

Conditions studied

  • Acanthosis Nigricans
03

In context

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 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
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • - male or female patients aged 18-50 years
  • clinically \& dermoscopy diagnosed acanthosis nigricans involving the neck
  • skin types iii-v
  • stable systemic condition for at least 3 months
  • willingness to comply with study protocol and follow-up

Exclusion criteria

Exclusion Criteria:

  • - pregnancy or lactation
  • -associated acanthosis nigricans
  • active skin infection or inflammatory dermatosis at the treatment site
  • history of keloid or hypertrophic scar formation
  • photosensitivity disorders
  • use of topical or systemic treatment for acanthosis nigricans within the last 4 weeks
  • previous laser treatment to the neck within the last 6 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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    Fractional CO₂ laser

    Drug: Topical metformin

Interventions

06

What researchers measure

Primary outcomes

  1. Assessment of severity using the acanthosis nigricans area and severity index (ANASI) score at baseline and after completion of treatment

    Time frame: 5-7 days

Secondary outcomes

  1. Physician global assessment (PGA)

    Time frame: 5-7 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.

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

Registered
Aug 7, 2026
First posted
Aug 12, 2026
StartEst.
Aug 10, 2026
Primary completionEst.
Aug 10, 2027
CompletionEst.
Sep 10, 2027
Last update
Aug 12, 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 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07760181
Responsible party
Ahmed Hamdan Abdellah (Ahmed Hamdan, Al-Azhar University) — Principal investigator
First posted
Aug 12, 2026
Start date
Aug 10, 2026 (estimated)
Primary completion
Aug 10, 2027 (estimated)
Completion
Sep 10, 2027 (estimated)
Last update
Aug 12, 2026

Oversight

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

Not currently enrolling

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

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Discussion

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Studies of the drug tested here: Metformin

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