临床试验/CTRI/2025/10/096563

CTRI/2025/10/096563尚未招募不适用

Evaluation of the irritation potential of Skin Care Formulations on healthy human subjects having varied skin type

RIVORA1 个研究点分布在 1 个国家目标入组 26 人开始时间: 2025年11月7日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 26
试验地点: 1
主要终点: Dermatological safety / Irritation potential on skin

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Objective:The objective of this study will be to evaluate the irritation potential on healthy human subjects having Varied skin types of Skin CareFormulations.

Kinetics: T0(before patch application), T1 day (0 hour after the patch removal), T2 days (24 hours after the patch removal ), T8 days (T+1 week after 0 hour of patch removal)

Population: 26healthy subjects (13 males + 13 females) .

The test area is checked for erythema and oedema caused due to the products and compared with positive control

研究设计

研究类型: Interventional
分配方式: Na
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit 3)Subjects representing varied skin type.

排除标准

•For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
•Having refused to give his/her assent by not signing the consent form.
•Taking part in another study liable to interfere with this study.
•Being diabetic.
•Being asthmatic.
•Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
•Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin).
•Having undergone a surgery requiring a general anesthesia of more than one hour in the past 6 months.
•Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.

结局指标

主要结局

Dermatological safety / Irritation potential on skin

时间窗: Baseline,0 hrs,24 hrs and 7 days

次要结局

未报告次要终点

研究者

发起方

RIVORA

申办方类型

Other [Personal Care or Beauty Industry]

责任方

Principal Investigator

主要研究者

Dr Niharika Salian

MASCOT-SPINCONTROL India Pvt. Ltd.

研究点 (1)

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