To assess the safety, tolerability, and suitability of Mother Sparsh Baby Wipes on Infant Skin compared to a cotton ball moistened with water.

Phase 4

Completed

• Registration Number: CTRI/2023/07/055838
• Lead Sponsor: Mother Sparsh Baby Care Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-09-12
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Healthy male and female infants aged between 1 to 12 months.

2. Routine users of baby wipes.

3. Subjects mother or legal guardian preferably mother willing to give written informed consent and adhere to all the study procedures.

4. Subjects must not participate in any other study during participation in the current study.

Exclusion Criteria

1. Subjects with had limb defects, admitted to the neonatal unit and receiving phototherapy

2. Subjects with non-traumatic impairment of epidermal integrity or evidence of skin disorder

3. Subjects with a chromosomal abnormality or other syndromic diagnosis

4. Subjects with known intolerance to baby wipes or baby wipes ingredients.

5. Subjects with psoriasis ichthyosis or a febrile illness.

6. Subjects taking any medication likely to influence the skin condition

7.Subjects mother or legal guardian preferably mother not willing to give informed consent

Study & Design

• Study Type: PMS
• Study Design: Not specified