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临床试验/CTRI/2018/04/013274
CTRI/2018/04/013274已完成2 期

Double blinded, randomized, controlled, single centered study to evaluate safety and efficacy of prickly heat powder.

ITC Limited Peenya Industrial Area Peenya Bangalore0 个研究点目标入组 63 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
63

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.70 volunteers of either gender in age group of 5 to 50 years. At least 10 volunteers in each of the following age brackets: (i) 5-10 yrs, (ii) 11-17 yrs (iii) 18-50 yrs.
  • 2.Volunteers with primary symptoms of Miliaria rubra on either of back/forearm/neck/ shoulder/chest/underarm/forehead or more than one of these.
  • 3.Volunteers with no history of having used a similar product during or since 1 week prior to the scheduled study commencement.
  • 4.Volunteers who show no skin sensitivity symptoms to the investigational products during skin sensitivity test.
  • 5.Female volunteers who are neither pregnant nor nursing.
  • 6.Volunteers who are willing to abstain from using any product other than the provided cleanser and test product during the study period.
  • 7.Volunteers willing to visit the site at specified frequencies for periodic evaluations.
  • 8.Volunteers willing to comply with study specific requirements.
  • 9.Volunteers willing to give a written informed consent and come for regular observation.

排除标准

  • 1.Volunteers with symptoms of Miliaria pustulosa, Miliaria profunda as identified by the dermatologist.
  • 2.Volunteers who have participated in similar kind of investigation in the past four weeks.
  • 3.Volunteers having infections on skin/ nail that could spread or interfere with the test readings.
  • 4.Volunteers with a known history or current condition of allergy or sensitivity to cosmetic products/ fragrances
  • 5.Volunteers on medications (e.g. steroids or antihistamines) that could compromise the study.
  • 6.Volunteers who are undergoing any medical treatment or taking any systemic medicines since 4 weeks prior to study commencement or applying any topical medication within 2 weeks prior to study commencement which could compromise the study.

研究者

发起方
ITC Limited Peenya Industrial Area Peenya Bangalore

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