Skip to main content
OpenTrials
Completed

NCT Number: NCT06213987

The Efficacy Tretinoin Cream in the Treatment of Axillary Hyperpigmentation Associated With Acanthosis Nigricans

The goal of this randomized intra-individual design with a split-side axillary approach is to comparing the efficacy of 0.025% tretinoin cream against a cream-based formulation in the treatment of axillary hyperpigmentation associated with acanthosis nigricans.

The main questions it aims to answer are:

* The efficacy of 0.025% tretinoin cream and cream based in the treatment of axillary hyperpigmentation associated with acanthosis nigricans. * The safety of 0.025% tretinoin cream and cream based in the treatment of axillary hyperpigmentation associated with acanthosis nigricans.

Participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arucha Treesirichod

Ongkharak, Changwat Nakhon Nayok, 26120, Thailand

About this study

This study employed a randomized intra-individual design with a split-side axillary approach, comparing the efficacy of 0.025% tretinoin cream against a cream-based formulation. Participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region. The efficacy of treatment was assessed by Mexameter (melanin index). The investigator's global evaluation (IGE) and parent's global evaluation (PGE) were also used to evaluate the overall success rate. The local safety was conducted for assessment of any cutaneous irritation. At each visit, the investigator graded the degrees of erythema, dryness, peeling, burning, and itching using a scale of 0 to 4. This study was followed for 4 visits, at the baseline, at week 2, 4 and 8.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The participants aged over 18 years with BMI more than 25 kg/m2, axillary hyperpigmentation associated with acanthosis nigricans

Exclusion criteria

  • Vulnerable skin diseases
  • Infectious skin diseases
  • Other recent diseases involving the axillary
  • Other serious medical disorders e.g. liver disease
  • Any patients having received other therapies for up to 4 weeks prior to enrollment
  • Photosensitive skin
  • Immunocompromised host
  • Pregnancy and lactation
  • Receiving oral retinoids
  • Axillary tattoo

Treatment and study plan

0.025% Tretinoin

Drug

Total duration of 8 weeks.

Primary outcomes

  1. Melanin index assessed by Mexameter

    Time frame: weeks 0, 2, 4 and week 8

    The outcome was treatment efficacy in reducing skin pigmentation, as represented by changes in melanin indices from Mexameter MX18.

Secondary outcomes

  1. Global evaluation scales

    Time frame: weeks 0, 2, 4 and week 8

    The outcomes were improvement in overall assessment using investigator global evaluation scales (IGE) and patient global evaluation scales (PGE), with scores ranging from 0 to 6 (0= clear, 1= almost clear or >90% improvement; 2= marked improvement or >75% improvement; 3= moderate improvement or >50% improvement; 4= mild improvement or >25% improvement; 5= no change; 6= worsening).

  2. Adverse cutaneous reactions

    Time frame: weeks 0, 2, 4 and week 8

    Adverse reactions were explored using the cutaneous irritation grading scales, in which participants rated erythema, dryness, peeling, burning each on a scale of 0 to 4, with 0 representing no adverse effect and 4 as marked severity.

Sponsors and collaborators

Lead sponsor

Srinakharinwirot University

Other

Registry information

Official study title

A Control Trial of the Efficacy and Safety of 0.025% Tretinoin Cream and Cream Based in the Treatment of Axillary Hyperpigmentation Associated With Acanthosis Nigricans

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2024
Registry last updated
Aug 13, 2024

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.

Published trials that share one or more normalized conditions with this study.