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Effect of baby products

A clinical study to evaluate the safety and efficacy of the baby care products on a healthy pediatric population of the age group 01-36 months.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041890
Enrollment
38
Registered
2022-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: RM.M480.67: Gently massage onto damp skin before bathing, after bathing and before night sleep. Duration - 28 days Control Intervention1: None: NA

Sponsors

Marico Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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. Subject’s mother/authorized legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up. 4. Subject’s mother/authorized legal representative, preferably mother willing to abide by and comply with the study protocol. 5. Subject’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

Exclusion criteria: 1. 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. 3. Babies whose parents and/or authorized legal guardian are not willing to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
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. 2. To evaluate the skin health and quality by dermatological assessment and instrumental evaluation in comparison to the baseline.Timepoint: 4 weeeks

Secondary

MeasureTime frame
NoneTimepoint: NA

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt Ltd

ritambhara@mscr.in08041125934

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026