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

Hyperpigmentation Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213987
• Other study ID #: 2566URMS0002
• Status: Recruiting
• Phase: Phase 3
• Start date: February 1, 2024
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Srinakharinwirot University
• Contact: Arucha Treesirichod
• Phone: 66815935232
• Email: trees_ar[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acanthosis Nigricans
• Hyperpigmentation

Intervention

Drug:
• 0.025% Tretinoin
Total duration of 8 weeks.

Locations

Country	Name	City	State
Thailand	Arucha Treesirichod	Ongkharak	Nakhonnayok

Sponsors (1)

Lead Sponsor	Collaborator
Srinakharinwirot University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melanin index assessed by Mexameter	The outcome was treatment efficacy in reducing skin pigmentation, as represented by changes in melanin indices from Mexameter MX18.	weeks 0, 2, 4 and week 8
Secondary	Global evaluation scales	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).	weeks 0, 2, 4 and week 8
Secondary	Adverse cutaneous reactions	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.	weeks 0, 2, 4 and week 8