Acanthosis Nigricans, Hyperpigmentation
Conditions
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.
Interventions
DRUG0.025% Tretinoin
Total duration of 8 weeks.
Sponsors
Srinakharinwirot University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Thailand
Outcome results
None listed