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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Melanin index assessed by Mexameter
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants aged over 18 years with BMI more than 25 kg/m2, axillary hyperpigmentation associated with acanthosis nigricans
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 0.025% Tretinoin (Drug)
Cream based
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.
干预措施: 0.025% Tretinoin (Drug)
结局指标
主要结局
Melanin index assessed by Mexameter
时间窗: 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.
次要结局
- Global evaluation scales(weeks 0, 2, 4 and week 8)
- Adverse cutaneous reactions(weeks 0, 2, 4 and week 8)
研究者
Arucha Treesirichod
Associate professor
Srinakharinwirot University