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

NCT06213987 | Completed Phase 3

• 1 other identifier: 2566URMS0002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acanthosis Nigricans; Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Global evaluation scales

  weeks 0, 2, 4 and week 8

• Adverse cutaneous reactions

  weeks 0, 2, 4 and week 8

Study Arms (2)

Tretinoin

EXPERIMENTAL

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

Cream based

PLACEBO COMPARATOR

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

Interventions

0.025% Tretinoin DRUG

Total duration of 8 weeks.

Cream based; Tretinoin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Srinakharinwirot University: lead

Study Sites (1)

Arucha Treesirichod

Ongkharak, Changwat Nakhon Nayok, 26120, Thailand

Location

MeSH Terms

Conditions

Acanthosis Nigricans; Hyperpigmentation

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Melanosis; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Arucha Treesirichod

  Srinakharinwirot University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: They were allocated the treatment via simple randomization by a third investigator who was not involved in data collection and analysis. Participants were given unlabeled jars of the topical agents. Assessments regarding clinical efficacy will be conducted by an assessor blind to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Intra-individual design with a split-side axillary approach, participants were randomly assigned to apply both 0.025% tretinoin cream and the cream-based product on opposing sides of the axillary region.

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 19, 2024
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data release will occur no later than 12 months after the publication of the primary study outcomes.
• 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

Locations

TH (1)