Safety and efficacy check of Prickly Heat Powder
- Registration Number
- CTRI/2023/05/053031
- Lead Sponsor
- ITC LIMITED ITC Life Sciences and Technology Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
1. 35 subjects of either gender in the age group of 19 to 50 yrs, with primary symptoms of Miliaria rubra on body (neck/ back / arms).
2. Subjects with no history of having used a similar product during or since 1 week prior to the scheduled study commencement.
3. Subjects who show no skin sensitivity symptoms to the investigational products during skin sensitivity test.
4. Subjects who are willing to abide by study protocol and specific restrictions.
1. Subjects who have participated in similar kind of investigation in the past four weeks.
2. Subjects having any infection on skin/ nail that could spread or interfere with the test readings / with a known history or current condition of allergy or sensitivity to cosmetic products/ fragrances.
3. Subjects who are undergoing any medical treatment or taking any systemic medicines since 4 weeks prior to study commencement or applying any topical medication in the past 2 weeks prior to study commencement which could compromise the study.
4. Female subjects who are either pregnant or nursing.
5. Subjects with symptoms of Miliaria pustulosa, Miliaria profunda as identified by the dermatologist.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Miliaria symptoms namely- <br/ ><br>- Eruption size / number / area covered/ Pruritis/ <br/ ><br>Erythema/ Oedema/ Excoriation over baseline. <br/ ><br>Timepoint: Baseline, Day 7, Day 14
- Secondary Outcome Measures
Name Time Method Safety and tolerance of a test productTimepoint: Baseline, Day 7, Day 14