To evaluate safety and efficacy of prickly heat powder.

Phase 2

Completed

• Conditions: Health Condition 1: null- Subjects showing symptoms of Miliaria rubra or Miliaria crystallina

• Registration Number: CTRI/2018/04/013274
• Lead Sponsor: ITC Limited Peenya Industrial Area Peenya Bangalore

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-06-28
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 63

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified