The Efficacy Tretinoin Cream in the Treatment of Axillary Hyperpigmentation Associated With Acanthosis Nigricans
- Conditions
- Acanthosis NigricansHyperpigmentation
- Interventions
- Drug: 0.025% Tretinoin
- Registration Number
- NCT06213987
- Lead Sponsor
- Srinakharinwirot University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- The participants aged over 18 years with BMI more than 25 kg/m2, axillary hyperpigmentation associated with acanthosis nigricans
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tretinoin 0.025% 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. Cream based 0.025% Tretinoin 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.
- Primary Outcome Measures
Name Time Method Melanin index assessed by Mexameter 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 Outcome Measures
Name Time Method Global evaluation scales 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).
Adverse cutaneous reactions 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.
Trial Locations
- Locations (1)
Arucha Treesirichod
🇹ðŸ‡Ongkharak, Nakhonnayok, Thailand