To evaluate the safety & Efficacy of Baby shampoo in babies of 0 months to 36 months

Phase 4

Completed

Registration Number: CTRI/2023/06/054326

Lead Sponsor: Emami Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

1.Subjects in the age group of 0 to 36 months (inclusive of both genders, equal number of male and female subjects).

2.Subjects in general good health as determined by the investigator.

3.Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.

4.Subjects mother/legal representative, preferably mother willing to abide by and comply with the study protocol.

5.Subjects should not participate in any other study during participation in the current study.

Exclusion Criteria

1. Babies with scalp / skin infection, history of hypersensitivity to study

products which may interfere in the study.

2. A known history or present condition of allergies that may require medical attention.

3. Chronic illness which may influence the skin condition.

4. Subjects not willing to stop the use of other shampoos during study period

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Evaluation of the mildness & gentleness on baby’s scalp on using Baby shampoo in babies of age group 0-36 months. <br/ ><br>2. To evaluate the prevention of tangling of hair after the use of Baby Shampoo <br/ ><br>3. No tears, all day long tangle free hair, smooth & shiny hair,cleanses gently & easy rinsability of the shampoo. <br/ ><br>4. To evaluate the safety of Baby Shampoo in babies of age group 0-36 months by local intolerance assessed by the investigatorTimepoint: Day 1 Day 14

Secondary Outcome Measures