Effect of baby products

Completed

Brief Summary: Study will be conducted to assess the safety and efficacy of the test products. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. For the selected subjects, the test products will be dispensed for the usage of 28 days. The assessment will be performed for week 1, 2 and 4.

Recruitment & Eligibility

Inclusion Criteria

Subjects in the age group 1-12 months, 12-24 months and 24-36 months in nearly equal ratio (both genders inclusive) 2.
Subjects in general good health as determined from a recent medical history 3.
Subjectâ€™s mother/authorized legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
Subjectâ€™s mother/authorized legal representative, preferably mother willing to abide by and comply with the study protocol.
Subjectâ€™s mother/legal representative agreeing not to use any other product of the same nature and change any habit or other regular products during the study period.

Exclusion Criteria

A known history or present condition or any other concern that may require medical attention 2.
Subejcts deemed unfit to participate in the study based on the general health and hygiene.
Babies whose parents and/or authorized legal guardian are not willing to sign the informed consent.

Primary Outcome Measures

Name	Time	Method
1.To evaluate the safety and efficacy of test products on a pediatric population by one month home use test in comparison to the baseline.	4 weeeks
2. To evaluate the skin health and quality by dermatological assessment and instrumental evaluation in comparison to the baseline.	4 weeeks

Secondary Outcome Measures

Name	Time	Method

Locations (1): MS Clinical Research Pvt. Ltd.
🇮🇳
Bangalore, KARNATAKA, India
MS Clinical Research Pvt. Ltd.
🇮🇳Bangalore, KARNATAKA, India
Dr Sharil Hegde
Principal investigator
08041125934
sharilhegde@yahoo.com