To check Safety, Tolerability and effectiveness of HBWW-052005

Not Applicable

Completed

• Registration Number: CTRI/2023/02/049841
• Lead Sponsor: Himalaya Wellness Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-04-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

1.Healthy subjects in the age group as below (inclusive of both genders)

a.Group 1: >=18-<=45 years (both inclusive)

b.Group 2: >= 2 - -<=12 years (both inclusive)

c.Group 3: 0 months â?? -<=2 years (both inclusive)

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified