NCT07618572招募中不适用
Study on the Functional Impact of Cosmetics on Improving Self-Esteem and Quality of Life in Black Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the use of dermocosmetics containing Bioceramides and Niacinamide can improve post-inflammatory hyperpigmentation and promote positive impacts on self-esteem and quality of life in Brazilian Black women with facial hyperpigmentation (Fitzpatrick skin types IV to VI).
The main questions it aims to answer are:
- Does the treatment improve hyperpigmentation severity as measured by HASI and IGA scores?
- Does the treatment improve participants' self-esteem and quality of life as assessed by MELASQoL and DLQI questionnaires?
Participants will:
- Use a standardized skincare routine including cleanser (0.2% Bioceramides), moisturizer (2% Niacinamide + 1% Bioceramides), serum (5% Niacinamide + 3% Bioceramides), and SPF 30 sunscreen for 12 weeks.
- Attend study visits at baseline, week 6, and week 12.
- Undergo standardized facial photography and clinical assessments by specialists at baseline, week 6, and week 12.
- Complete questionnaires related to self-esteem and quality of life at baseline, week 6, and week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 to 55 years
- •Clinical diagnosis of facial post-inflammatory hyperpigmentation (PIH)
- •Self-identified as Black (including "preta" or "parda")
- •Fitzpatrick skin types IV to VI
- •Employees, students, or affiliated personnel of Hospital Israelita Albert Einstein (including contractors and fellows), recruited from institution units
- •Willing and able to comply with all study procedures and attend all scheduled visits
- •Able and willing to provide written informed consent and authorization for image use
排除标准
- •Pregnant or breastfeeding women, or those planning pregnancy during the study period
- •Type 1 diabetes mellitus or related complications (e.g., nephropathy, dermatological conditions associated with diabetes, history of hypoglycemia, diabetic ketoacidosis, or hyperosmolar coma)
- •Known or suspected intolerance to similar cosmetic products
- •History of atopy or allergic reactions to cosmetic products
- •Personal or family history of skin cancer
- •Active skin conditions or lesions affecting the face
- •Facial marks or scars that may interfere with assessments
- •Skin irritation due to recent sun exposure
- •Excessive sun or UV exposure, including artificial tanning, within the past month
- •Use of facial cosmetic products within 7 days before screening
- •Use of topical or systemic treatments within 1 month before screening
- •Use of depigmentation treatments within 3 months before screening
- •Use of dermocosmetic treatments for PIH within 3 months before screening
- •Facial dermatological or aesthetic procedures within 2 weeks before screening
- •Use of corticosteroids, anticoagulants, or immunosuppressive drugs
- •Score ≥5 indicating anxiety or depression on Patient Health Questionnaire (PHQ-9) or Generalized Anxiety Disorder scale (GAD-7)
- •Any other condition that, in the investigator's judgment, may compromise study participation or results (to be documented in the medical record)
研究者
研究点 (1)
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