Clinical Evaluation of Acetyl Hexapeptide-37 in a Topical Formulation on Forehead Skin Barrier: a Doubleblind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
The goal of this clinical trial is to evaluate whether a topical face cream containing the peptide Acetyl Hexapeptide-37 improves skin hydration and strengthens the skin barrier compared to a placebo cream in healthy adult participants. The study uses a split-face design, in which one side of the face is treated with the peptide cream and the other side with a placebo (a cream without the active ingredient).
The main questions it aims to answer are:
- Does the peptide cream improve skin hydration and reduce transepidermal water loss compared to placebo?
- Does the peptide cream affect skin erythema or cause irritation?
- How do participants rate the comfort and tolerability of the peptide cream?
Researchers will compare the treated and placebo sides of the face to assess differences in skin barrier function and tolerability.
Participants will:
- Attend a baseline visit for assessment of facial skin parameters, including hydration, transepidermal water loss, and erythema
- Apply the peptide cream to one side of the face and the placebo cream to the other side once daily for 4 weeks
- Attend weekly follow-up visits for non-invasive skin measurements
- Record any skin sensations (e.g., stinging, tightness) or adverse effects throughout the study
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers who gave written informed consent
排除标准
- •presence of active skin diseases or dermatological conditions
- •known allergy or hypersensitivity to any ingredient of the study products
- •pregnancy or breastfeeding
- •use of topical or systemic corticosteroids, immunosuppressive drugs, or antihistamines prior to or during the study
研究组 & 干预措施
Peptide Cream (Acetyl Hexapeptide-37)
Participants will apply a topical cream containing Acetyl Hexapeptide-37 to one side of the face once daily for 4 weeks. The side of application (left or right) will be determined according to the randomization protocol.
干预措施: Acetyl Hexapeptide-37 Cream (Other)
Placebo Cream
Participants will apply a placebo cream (an identical emollient formulation without the peptide) to the contralateral side of the face once daily for 4 weeks. The side of application (left or right) will be determined according to the randomization protocol.
干预措施: Placebo Cream (Other)