To evaluate the in vivo safety and efficacy of the skin care formulations in terms of hair removal effect on healthy human subjects

RG Biocosmetics1 个研究点分布在 1 个国家目标入组 33 人开始时间: 2026年1月14日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 33
试验地点: 1

研究概览研究设计入排标准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 is to evaluate the in-vivo safety and efficacy of the skin care formulations in terms of hair removal effect on healthy human subjectsThe evaluation is performed using: Subject Self Evaluation (SSE), Dermatological Evaluation: Cosmetic Acceptability, Expert Assessment

POPULATION:33 subjects (17/16 males and 16/17 females) will be selected for the study. The subjects selected for this study are healthy males & females aged between 18 and 40 years, having terminal hair in the areas to be treated and having a habit of using hair removal cream and hair removal spray.

STUDY DURATION: 1 hour following the first application of the product.

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 40.00 Year(s)（—）
性别: All

入选标准

•Indian male and female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having terminal hair in the areas to be treated.
•Having a habit of using hair removal cream and hair removal spray.

排除标准

•For Females: Being pregnant or breastfeeding or having stopped breastfeeding in the past three months.
•Having refused to give his/her assent by not signing the consent form 3)Taking part in another study liable to interfere with this study 4)Being allergic to use of powder, removal cream/ spray on study site.
•Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6)Having a progressive asthma (either under treatment or last fit in the last 2 years) 7)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9)Being epileptic.
•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.
•Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
•Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
•Having changed cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.

研究者

发起方

RG Biocosmetics

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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