None listed
Conditions
Interventions
Intervention1: HBWW-052005 - Baby Water Wipes: How to Use: Pull out 1 wipe & gently clean the baby.
Frequency: Use as and when required
Time period: 3 days - Group 1, 2 and
28 days - Group 3, 4.
Con
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy subjects in the age group as below (inclusive of both genders) a.Group 1: >=18- b.Group 2: >= 2 - - c.Group 3: 0 months â?? - d.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.
Exclusion criteria
Exclusion criteria: 1.A known history or present condition of allergic response to any other concern that may require medical attention. 2.Chronic illness which may influence the cutaneous state. 3.Subjects not willing to stop the use of other baby powders during the study period. 4.Subjects participated in any other clinical study past 4 weeks 5.To determine the experience of test product on baby skin through subjective questionnaires on cleaning as pure as water, gentle cleansing without making skin dry for new-born skin, Suitable/ safe for newborn skin, suitable for sensitive skin babies, safe for use from day 1 of the baby, suitable/ safe for premature baby. keeps skin refreshed, keeps baby skin soft and smooth, mildness and gentleness tested in babies and safe on new-born 6.Local tolerance evaluation by the investigator. 7.Monitoring of AEs and SAEs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the skin mildness, gentleness and irritability on skin by the investigator.Timepoint: 1. 2 - 12 years Day 01 and Day 03 2. 18 - 45 years: Day 01 and Day 03 3. 0 - 2 Years: Day1, Day 7, Day 28 4. Premature babies: Day1, Day 7, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the experience of test product on baby skin through subjective questionnairesTimepoint: 2 - 12 years, 18 - 45 years: Day 03 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 0 - 2 Years, Premature babies: Day 7, Day 28 | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed