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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06213987
Other study ID # 2566URMS0002
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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