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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperpigmentation; Acanthosis Nigricans
• Intervention / Treatment: Drug: 0.025% Tretinoin

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Nakhonnayok
    • Ongkharak, Nakhonnayok, Thailand, 26120
      • Arucha Treesirichod

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tretinoin; Apply 1 gram of tretinoin cream to the axillary region before bedtime once every other day during the first two weeks, and then once daily after that, total duration of 8 weeks.	Drug: 0.025% Tretinoin; Total duration of 8 weeks.
Placebo Comparator: Cream based; Apply 1 gram of cream based to the axillary region on the opposing side before bedtime once every other day during the first two weeks, and then once daily after that, total duration of 8 weeks.	Drug: 0.025% Tretinoin; Total duration of 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Srinakharinwirot University
• Investigators: Principal Investigator: Arucha Treesirichod, Srinakharinwirot University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Melanosis; Acanthosis Nigricans; Hyperpigmentation; Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: 2566URMS0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with our commitment to transparency and advancing scientific knowledge, individual participant data collected during this study will be made available for sharing. The data will be accessible to qualified researchers upon request, subject to approval by the data sharing committee.
• IPD Sharing Time Frame: The data release will occur no later than 12 months after the publication of the primary study outcomes.
• IPD Sharing Access Criteria: Access to the data will be granted based on a set of predefined criteria, and interested parties will be required to submit a formal request outlining the purpose of data usage and plans for analysis. A data sharing agreement may be required to ensure compliance with ethical standards and the protection of participant privacy. For inquiries or to request access to the data, please contact trees_ar@yahoo.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No