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To evaluate the safety and efficacy of soothing calamine baby lotion in 0-36 months babies.

PMOS to evaluate the safety and efficacy of soothing calamine baby lotion in 0-36 months babies.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/10/037299
Enrollment
500
Registered
2021-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

None listed

Interventions

Intervention1: Soothing Calamine lotion: Himalaya Soothing Calamine Baby Lotion leaves babyâ??s skin moisturized, soothes the red and irritated skin. It contains Rasaka (calamine), which is commonly u

Sponsors

Himalaya Wellness Company
Lead Sponsor
JSS Medical Research Asia Pacific Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Subjects in the age group of 0 to 36 months (inclusive of both genders). Subjects in general good health as determined from a recent medical history and physical examination. Subjects also with any 1 of these conditions prickly heat, insect bites and hives Subjects showing at least 1 or more of the skin irritation symptoms such as itchiness, red patches, skin rashes and skin allergies. Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to comply with the study protocol.

Exclusion criteria

Exclusion criteria: A known history or present allergic condition that may require medical attention. Chronic illness which may influence the cutaneous assessment. Subjects not willing to stop the use of other lotions during study period.

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and efficacy of Test Product in study population.Timepoint: Study duration: This study is planned for 15 days.

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMs Sushma C

Himalaya Wellness Company

dr.swathi.b@himalayawellness.com08067547232

Outcome results

None listed

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