To evaluate the safety and efficacy of diaper rash cream in 0-36 months babies.
Phase 4
Completed
- Registration Number
- CTRI/2021/10/037472
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
•Subjects in the age group of 0 to 36 months (inclusive of both genders)
•Subjects in general good health as determined from a recent medical history and physical examination.
•Subjects showing at least 1 or more symptoms of diaper rashes (diaper dermatitis) such as itching, redness and rashes.
•Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to comply with the study protocol.
Exclusion Criteria
•A known history or present allergic condition that may require medical attention
•Chronic illness which may influence the cutaneous assessment
•Subjects not willing to stop the use of other creams during study period
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety and efficacy of Test Product in study populationTimepoint: Study duration: This study is planned for 15 days
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable