To evaluate the safety and efficacy of crème cleansing baby bar in 0-36 months babies.
Phase 4
Suspended
- Registration Number
- CTRI/2021/10/037326
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
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 also with at least one symptom of atopic dermatitis like dry skin, itchy skin, scaly skin
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 soaps 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: Primary outcome: Dermatology assessment for mildness and gentleness of babyâ??s skin <br/ ><br> <br/ ><br>Timepoints: Baseline and 2 weeks <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable