To evaluate the safety and efficacy of diaper rash cream in 0-36 months babies.

PMOS to evaluate the safety and efficacy of diaper rash cream in 0-36 months babies.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/10/037472

Enrollment

500

Registered

2021-10-22

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: Diaper Rash Cream: Route of administration â?? Topical application , Frequency â?? As directed by investigator , Duration of therapy â?? 14 days Control Intervention1: Not Applicable

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 showing at least 1 or more symptoms of diaper rashes (diaper dermatitis) such as itching, redness and rashes. •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 creams during study period

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and efficacy of Test Product in study populationTimepoint: Study duration: This study is planned for 15 days	—

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