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NCT Number: NCT07760181

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

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

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Key information

Conditions

Acanthosis Nigricans Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • - 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

Treatment and study plan

Topical metformin

Drug

applied to one half of the neck only

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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Efficacy and Safety Of Fractional Carbon Dioxide Laser Plus Topical Metformin In Treatment Of Acanthosis Nigricans: A Comparative Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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