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临床试验/NCT03252730
NCT03252730已完成不适用

In-Use Test With a Cosmetic Product (WO 4260) for Topical Use on the Scalp

Dr. August Wolff GmbH & Co. KG Arzneimittel1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Tolerance of the Test Product on the Scalp

研究概览

简要总结

The aim of the study is to evaluate the tolerance of the product WO 4260 by a dermatologist. Additional objectives of this clinical in-use study are to evaluate the cosmetic features and acceptance of the product by means of a questionnaire in an interview situation and by skin hydration measurements on the scalp.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age: ≥ 18 years
  • •sex: approx. 50% male and approx. 50% female
  • •users of hair tonic for dry scalp
  • •dry, itchy scalp prone to atopic eczema / atopic dermatitis

排除标准

  • •any deviation from the above-mentioned criteria
  • •users of sour hair rinse
  • •subjects who wash their hair more than once a day
  • •other dermatological disorders (scars, moles) on the scalp
  • •known incompatibilities to cosmetics and ingredients of cosmetic test products (please see INCI)
  • •topical medication in the test area within 1 month prior to study start
  • •systemic medication with anti-inflammatory agents and antibiotics within 2 weeks prior to starting of the study
  • •systemic medication with retinoids, antihistamines and/or immunomodulators (e.g. cortisone, corticosterone, chemotherapeutic agents) within 4 weeks prior to starting of the study
  • •systemic illness of the subject at the beginning of the study
  • •pregnancy and period of breastfeeding

研究组 & 干预措施

WO 4260 Cosmetic Product for Topical Use

Experimental

WO 4260 is used to treat dry and itchy scalp

干预措施: WO 4260 Cosmetic Product for Topical Use (Other)

结局指标

主要结局

Tolerance of the Test Product on the Scalp

时间窗: after 4 weeks of treatment

Change from Baseline Tolerance on the Scalp at 4 weeks

次要结局

  • Skin Hydration of the Scalp(before product treatment; after 2 and 4 weeks of treatment)
  • Performance of the Test Product(after 4 weeks of treatment)
  • Tolerance of the Test Product on the Scalp(after 2 weeks of treatment)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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