NCT05888311已完成不适用
Randomized, Open Clinical Study to Evaluate the Protective Potential of a Liquid Bandage Based on Liquid Elastic Collodion Versus no Treatment
Eurofarma Laboratorios S.A.2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年2月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Efficacy of the investigational product in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
研究概览
简要总结
This study was designed with the objective of evaluating the protection potential provided by the experimental product (Liquid Bandage) by evaluating its barrier formation capacity. Once the product's ability to form a barrier is confirmed, its ability to protect against small skin injuries, such as small cuts and bruises, blisters and cracks, is confirmed. The barrier formation also guarantees protection against the formation of calluses.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years old.
- •Fitzpatrick skin phototype classification I to IV.
- •Presence of intact skin in the test region (right forearm and left forearm for selected participants).
- •Agreement to adhere to the study procedures and requirements and attend the institute on the days and times determined for the assessments.
- •Signing of the Informed Consent Form (ICF) and the Image Disclosure Consent Form (IDCF) before carrying out any study procedure.
排除标准
- •Diagnosis of skin diseases such as vitiligo, psoriasis, atopic dermatitis.
- •Diagnosis of immunological insufficiency.
- •Use of systemic corticosteroids or immunosuppressants.
- •Diagnosis of type 1 diabetes mellitus or insulin-dependent diabetes or presence of complications resulting from diabetes (such as retinopathy, nephropathy, neuropathy), presence of diabetes-related dermatoses (such as plantar ulcers, lipoid necrobiosis, granuloma annulare, opportunistic infections), history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma.
- •History of reaction to liquid dressings.
- •Known hypersensitivity to any ingredients of investigational product formulation.
- •Other diseases or use of drugs that may directly interfere with the study or put the research participant's health at risk.
- •Presence of any serious or uncontrolled diseases, at the investigator's discretion.
- •Pregnancy or lactation.
- •Participation in a clinical research protocol in the last 12 months, unless, at the investigator's discretion, their participation in the study may result in direct benefit to the participant.
- •Presence of any conditions that, at the investigator's discretion, make the participant unable to participate in the study.
结局指标
主要结局
Efficacy of the investigational product in barrier formation, showing its superiority versus no treatment (control) through transepidermal water loss 12 hours after its administration.
时间窗: 12 hours
Evaluation of barrier formation through transepidermal water loss range 12 hours (± 20 minutes) after the end of tape stripping (TEWL12h) versus the measurement obtained immediately after tape stripping (TEWL0).
次要结局
- Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 3 minutes after its administration(3 minutes)
- Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 6 hours after its administration.(6 hours)
- Evaluate the efficacy of the investigational product in barrier formation through the range of transepidermal water loss 24 hours after its administration(24 hours)
- Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 3 minutes after its administration(3 minutes)
- Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 6 hours after its administration(6 hours)
- Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 12 hours after its administration(12 hours)
- Evaluate the efficacy of the investigational product in barrier formation through the range of corneometry 24 hours after its administration(24 hours)
- Evaluate the investigational product water resistance after four washes(12 hours)
研究者
研究点 (2)
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