Acanthosis NigricansPhase 1NCT07760181
Efficacy and Safety Of Fractional Carbon Dioxide Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans
A Phase 1 study testing Topical metformin in people with Acanthosis Nigricans, run by Al-Azhar University.
Trial summary
evaluate and compare the clinical Efficacy \& Safety Of Fractional Carbon Dioxide (Co₂) Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acanthosis Nigricans
- What is being tested?
- Topical metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2026to 10 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- - 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
Who cannot join
- - pregnancy or lactation
- malignancy-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
About this study
Official title: Efficacy and Safety Of Fractional Carbon Dioxide Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans: A Comparative Study
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
- Conditions
- Acanthosis Nigricans
- Being tested
- Topical metformin
- Medical subject headings
- Acanthosis Nigricans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical metforminDrug
applied to one half of the neck only
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO₂ laser | Active comparator | Not described Receives: Drug: Topical metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of severity using the acanthosis nigricans area and severity index (ANASI) score at baseline and after completion of treatment
Measured: 5-7 days
Secondary outcomes (1)
Physician global assessment (PGA)
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion10 Aug 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
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 Al-Azhar 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hamdan Abdellah, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760181
- Sponsor's protocol ID
- Acanthosis Nigricans
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Of Fractional Carbon Dioxide Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans: A Comparative Study
- ClinicalTrials.gov ID
- NCT07760181
- Acronym / sponsor ID
- Acanthosis Nigricans
- Conditions
- Acanthosis Nigricans
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 12 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.
evaluate and compare the clinical Efficacy \& Safety Of Fractional Carbon Dioxide (Co₂) Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional CO₂ laser | Active comparator | Drug: Topical metformin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (7 listed)
- - pregnancy or lactation
- malignancy-associated acanthosis nigricans
- active skin infection or inflammatory dermatosis at the treatment site
- history of keloid or hypertrophic scar formation
- photosensitivity disorders
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 |
|---|---|---|
| Topical metforminapplied to one half of the neck only | Drug | Fractional CO₂ laser |
Primary outcome
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
1 secondary outcome
Physician global assessment (PGA)
Time frame: 5-7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topical metformin in people with Acanthosis Nigricans, run by Al-Azhar University.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
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). 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 12 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.