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

PMOS to evaluate the safety and efficacy of crÃ¨me cleansing baby bar in 0-36 months babies.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/10/037326

Enrollment

500

Registered

2021-10-14

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: CrÃ¨me cleansing baby bar: Route of administration â?? Topical application, Frequency â?? As and when required, Duration of therapy will be 14 days Control Intervention1: Not Applic

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 at least one symptom of atopic dermatitis like dry skin, itchy skin, scaly skin 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 soaps during study period

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and efficacy of Test Product in study populationTimepoint: Primary outcome: Dermatology assessment for mildness and gentleness of babyâ??s skin Timepoints: Baseline and 2 weeks	—

Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactMs Sushma C

Himalaya Wellness Company

dr.swathi.b@himalayawellness.com8067547232

Outcome results