Safety and Efficacy of Skincare Products for Managing Mild to Moderate Acne in Individuals With Sensitive Skin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Comprehensive Acne Severity Scale Classification (CASS)
研究概览
简要总结
To investigate the safety and efficacy of a skincare regimen in individuals with mild to moderate acne and sensitive skin. The study duration is 4 weeks and the skin assessment will be carried out at baseline and week 4.
The main questions this study aims to answer are:
- To investigate the safety of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
- To determine the efficacy of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
- To assess the participants' satisfaction with the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy Malaysian women and men
- •Fitzpatrick skin type II-V
- •Age above 18 years old
- •Individuals with sensitive skin identify through sensitive skin survey (Corazza et al., 2022) and lactic acid sting test (LAST).
- •Individuals with mild to moderate acne, based on Comprehensive Acne Severity Scale (CASS)
排除标准
- •Pregnant or breastfeeding women, or those planning pregnancy during the study period.
- •Individuals with documented autoimmune diseases or other conditions that may affect immune response or skin barrier function.
- •Individuals with a history of severe skin sensitivity reactions, including frequent intense erythema, swelling, or intolerable burning in response to topical products.
- •Individuals with severe acne requiring medical treatment or systemic treatment such as nodulocystic acne.
- •Individuals with active inflammatory or allergic dermatological conditions affecting the face, such as atopic dermatitis, eczema, or psoriasis, which may compromise skin barrier function or interfere with study assessments.
- •Individuals who have undergone cosmetic or dermatological procedures such as -chemical peel, microneedling, or any procedures aimed at improving acne, within 3 months prior to the study.
- •Individuals currently taking medical or hormonal treatments that may interfere with study outcomes, including anti-inflammatory agents, corticosteroids, or other medication interfering with study objectives.
- •Individuals with known allergy or hypersensitivity to any ingredients found in the product.
研究组 & 干预措施
Skincare regimen
The skincare regimen consist of cleanser, toner, serum, day cream and night cream
干预措施: Cleanser (Other)
Skincare regimen
The skincare regimen consist of cleanser, toner, serum, day cream and night cream
干预措施: Toner (Other)
Skincare regimen
The skincare regimen consist of cleanser, toner, serum, day cream and night cream
干预措施: Serum (Other)
Skincare regimen
The skincare regimen consist of cleanser, toner, serum, day cream and night cream
干预措施: Day cream (Other)
Skincare regimen
The skincare regimen consist of cleanser, toner, serum, day cream and night cream
干预措施: Night cream (Other)
结局指标
主要结局
Comprehensive Acne Severity Scale Classification (CASS)
时间窗: baseline, week 4
Improvement of acne lesions will be assessed by blinded clinician at W0 and W4 of the study, using CASS. Acne severity was graded using a 6-point scale ranging from Grade 0 (clear) to Grade 5 (very severe). Grade 0 (clear)= No lesions to barely noticeable ones. Very few scattered comedones and papules; Grade 1 (almost clear) = Hardly visible from 2.5 metres away. A few scattered comedones, few small papules, and very few pustules; Grade 2 (mild)= Easily recognisable; less than half of the affected area is involved. Many comedones, papules, and pustules; Grade 3 (moderate)= More than half of the affected area is involved. Numerous comedones, papules, and pustules; Grade 4 (severe)= Entire area is involved. Covered with comedones, numerous pustules and papules, a few nodules and cyst; Grade 5 (very severe)= Highly inflammatory acne covering the affected area, with nodules, and cyst present.
Acne lesion counts
时间窗: baseline, week 4
Acne lesion counts will be performed by a blinded clinician. It will involve quantifying the open comedones, closed comedones, papules, pustules, nodules, and cysts. Lesions will be assessed across 5 facial regions: right forehead, left forehead, right cheek, left cheek, and chin. The nose and perinasal area will be excluded from analysis.
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](4 weeks)
- Participant satisfaction(week 4)