The Efficacy Tretinoin Cream in the Treatment of Axillary Hyperpigmentation Associated With Acanthosis Nigricans

Srinakharinwirot University

Status and phase: Completed; Phase 3

Conditions: Hyperpigmentation; Acanthosis Nigricans

Treatments: Drug: 0.025% Tretinoin

Study type: Interventional

Funder types: Other

Identifiers

NCT06213987

2566URMS0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Tretinoin

Experimental group

Description:

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.

Treatment:

Drug: 0.025% Tretinoin

Cream based

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.025% Tretinoin