MedPath

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

Phase 4
Suspended
Registration Number
CTRI/2021/10/037299
Lead Sponsor
Himalaya Wellness Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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