Clinical trial NCT06213987: The Efficacy Tretinoin Cream in the Treatment of Axillary Hyperpigmentation Associated With Acanthosis Nigricans
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acanthosis Nigricans
Hyperpigmentation
Lead sponsor: Srinakharinwirot University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Melanin index assessed by Mexameter
timeFrame: weeks 0, 2, 4 and week 8
Secondary outcomes:
measure: Global evaluation scales
timeFrame: weeks 0, 2, 4 and week 8
measure: Adverse cutaneous reactions
timeFrame: weeks 0, 2, 4 and week 8
Other outcomes:
Locations:
city: Ongkharak
country: Thailand
facility: Arucha Treesirichod
state: Nakhonnayok
Study officials:
affiliation: Srinakharinwirot University
name: Arucha Treesirichod
role: PRINCIPAL_INVESTIGATOR
References: