To assess the Safety, Tolerability andIn-use effectiveness of HBWW-052005
- Registration Number
- CTRI/2022/12/047967
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
1.Healthy subjects in the age group as below (inclusive of both genders).
Group 1: >=18-<=45 years (both inclusive).
Group 2: >= 2 - -<=12 years (both inclusive).
Group 3: 0 months â?? -<=2 years (both inclusive).
Group 4: Premature babies (babies born before 37 weeks).
2.Healthy day 1 babies not requiring medical attention.
3.Babies with signs of atopic dermatitis (dry skin, itchy skin, redness, sensitive skin, rashes) who does not require medical/ systemic treatment to be included. Included in group 2 (6 subjects) and group 3 (15 subjects) with signs of atopic dermatitis.
4.Subjects in general good health as determined from a recent medical history.
5.Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
6.Subjects mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
7.Subjects should not participate in any other clinical study during participation in the current study.
A known history or present condition of allergic response to any
other concern that may require medical attention.
• Chronic illness which may influence the cutaneous state.
• Subjects not willing to stop the use of other baby powders
during the study period.
• Subjects participated in any other clinical study past 4 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the skin mildness, gentleness and irritability on skin by the investigator.Timepoint: 1. 2 - 12 years Day 01 and Day 03 <br/ ><br>2. 18 - 45 years: Day 01 and Day 03 <br/ ><br>3. 0 - 2 Years: Day1, Day 7, Day 28 <br/ ><br>4. Premature babies: Day1, Day 7, Day 28
- Secondary Outcome Measures
Name Time Method To determine the experience of test product on baby skin through subjective questionnairesTimepoint: 2 - 12 years, 18 - 45 years: Day 03 <br/ ><br>0 - 2 Years, Premature babies: Day 7, Day 28;To evaluate the product safety of skin by local intolerance evaluation by investigatorTimepoint: 2 - 12 years, 18 - 45 years: Day 03 <br/ ><br>0 - 2 Years, Premature babies: Day 7, Day 28