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Safety and efficacy check of Prickly Heat Powder

Evaluation of Dermatological safety and Anti Miliaria Efficacy of Test Product on Healthy Human Subjects of Varied Skin Types

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/053031
Enrollment
35
Registered
2023-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Prickly Heat Powder (14-124): Adequate quantity of Product to be applied twice daily at morning and night before going to bed on Miliaria affected regions for the period of 14 days. Con

Sponsors

ITC LIMITED ITC Life Sciences and Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Reduction in Miliaria symptoms namely- - Eruption size / number / area covered/ Pruritis/ Erythema/ Oedema/ Excoriation over baseline. Timepoint: Baseline, Day 7, Day 14

Secondary

MeasureTime frame
Safety and tolerance of a test productTimepoint: Baseline, Day 7, Day 14

Countries

India

Contacts

Public ContactMr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026