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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Arucha Treesirichod | Ongkharak | Nakhonnayok |
Lead Sponsor | Collaborator |
---|---|
Srinakharinwirot University |
Thailand,
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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