MedPath

To evaluate the safety and efficacy of Crème cleansing baby bar in 0-36 months babies.

Phase 4
Conditions
Health Condition 1: L208- Other atopic dermatitis
Registration Number
CTRI/2023/10/058788
Lead Sponsor
Himalaya Wellness Company
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Subjects in the age group of 0 to 36 months (inclusive of both genders).

2.Subjects with Atopic Dermatitis with at least one of the following symptoms: dryness, itchiness, redness, flaky skin.

3.Subjects in general good health as determined by investigator.

4.Subjects mother/legal representative willing to give a voluntary written parent consent and agree to complete study activities and come for regular follow up with subject.

Exclusion Criteria

1.A known history or present allergic condition that may require medical attention.

2.Chronic illness which may influence the cutaneous assessment.

3.Subjects not willing to stop the use of other baby bath products or soap during the study product.

4.Subjects who have participated in a similar clinical investigation in the past four weeks.

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the safety and efficacy of Test Product in study population.Timepoint: 14 days
Secondary Outcome Measures
NameTimeMethod
ATimepoint: NA
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