NCT07760181

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
13mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Sep 2027

First Submitted

Initial submission to the registry

August 7, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 10, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2027

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Acanthosis Nigricans

Outcome Measures

Primary Outcomes (1)

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

    5-7 days

Secondary Outcomes (1)

  • Physician global assessment (PGA)

    5-7 days

Study Arms (1)

Fractional CO₂ laser

ACTIVE COMPARATOR
Drug: Topical metformin

Interventions

Topical metforminDRUG

applied to one half of the neck only

Fractional CO₂ laser

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acanthosis Nigricans

Interventions

Metformin

Condition Hierarchy (Ancestors)

MelanosisHyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ahmed Hamdan

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start

August 10, 2026

Primary Completion (Estimated)

August 10, 2027

Study Completion (Estimated)

September 10, 2027

Last Updated

August 12, 2026

Record last verified: 2026-08