Evaluation of the Efficacy of a Topical Formulation Containing Acetyl Hexapeptide-37 on Skin Barrier Recovery of the Forearm After Controlled Damage Using the Tape-stripping Method
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of a topical peptide-based formulation containing Acetyl Hexapeptide-37 in promoting skin barrier recovery after controlled disruption in healthy adult participants.
The main questions it aims to answer are:
- Does the peptide cream speed up the recovery of the skin barrier after it has been slightly damaged with tape-stripping method?
- How does the peptide cream compare to a placebo (a cream with no active ingredient) in improving skin hydration and reducing redness?
Researchers will compare the peptide cream to a placebo to assess its effects on skin barrier recovery
Participants will:
- Undergo controlled disruption of the skin barrier on the volar forearm using the tape-stripping method.
- One forearm will receive the peptide-based cream containing Acetyl Hexapeptide-37, while the other (contralateral) forearm will receive a placebo formulation.
- Attend scheduled visits for non-invasive assessments of skin barrier function, including transepidermal water loss, skin hydration, and erythema
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
- •skin disease
- •skin damage on measurement sites
- •use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
- •use of emollients three days prior the inclusion in the trial
- •non-adherence to the trial protocol
- •exposure to artificial and excessive natural ultraviolet (UV) radiation
- •pregnancy or breastfeeding
- •immunosuppression
- •allergic or irritant reactions to the constituents of the cream
研究组 & 干预措施
Placebo treatment
The other forearm will be treated with a placebo ointment. The allocation of the treatment (left or right forearm) will be determined according to the randomization protocol.
干预措施: Placebo (Other)
Active treatment
One forearm will be treated with the peptide-based cream containing Acetyl Hexapeptide-37. The treated forearm (left or right) will be assigned according to the randomization protocol.
干预措施: Acetyl Hexapeptide-37 (Other)
Untreated Control Site
A designated skin site on either forearm will undergo tape-stripping to induce skin barrier disruption but will not receive any topical treatment. This site will serve as a control for natural skin barrier recovery.