To evaluate the efficacy of a cosmetic/ayurvedic formulation in the treatment of Miliaria (Prickly Heat)

Phase 4

Completed

• Conditions: Miliaria (Prickly Heat)

• Registration Number: CTRI/2013/07/003822
• Lead Sponsor: CHOLAYIL PVT LTD

Brief Summary

This is an open label, single centered clinicalstudy. There will be only children (male and female) volunteers in thestudy. Total 30 + 5 subjects will be enrolled in the study. This will be a 5days study. All the subjects will be assessed on Baseline, day 3 and day 5.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-05
• Last Update Posted: 2013-09-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• 1.Volunteer in generally good health.
• 2.Volunteer between the ages of 05 to 12 years.
• 3.Volunteer with primary miliaria.
• 4.Volunteer has not participated in a similar clinical investigation in the past four weeks.
• 5.Volunteer willing to abstain from using any cosmetic/medical product on the test site during the entire study course.
• 6.Volunteer willing to visit the site on scheduled visit.
• 7.Volunteer willing to give a sign a written assent form and come for regular observation.

Exclusion Criteria

• 1.A known history or present condition of allergic response to any cosmetic products.
• 2.Skin disease except Miliaria (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations), which would interfere with the test readings.
• 3.Medications (e.g. steroids or antihistamines), which would compromise the study.
• 4.Currently or has been undergoing dermatologist treatments or procedures within the last 1 month.
• 5.Volunteer viewed by the investigator as not being able to complete the study or participating in another study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To ascertain the efficacy of the investigational product in reducing the miliaria.	Baseline (day 1), day 3 and day 5.

Secondary Outcome Measures

Name	Time	Method
Reducing irritation	Baseline (day 1), day 3 and day 5.

Trial Locations

Locations (1)

KETs Scientific Research Centre; 🇮🇳 (Suburban), MAHARASHTRA, India

KETs Scientific Research Centre

🇮🇳(Suburban), MAHARASHTRA, India

Ms Meghana Surve

Principal investigator

02225639644

meghana@kelkarcosmetology.com