To Evaluate the Safety and Efficacy of Baby Soap in 0-36 Months Babies

Post Marketing Observational Study (PMOS) to Evaluate the Safety and Efficacy of Extra Moisturizing Baby Soap in 0-36 Months Babies - EMBS

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/03/023827

Enrollment

200

Registered

2020-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Extra Moisturizing Baby Soap: dose, frequency route of administration and duration of therapy: Wet the babyâ??s body and face with water, apply the soap generously, work up lather and r

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. Subjects with dry skin will be enrolled in the study. 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 Extra Moisturizing Baby Soap in study population.Timepoint: Study duration: This study is planned for 8 days.	—

Secondary

Measure	Time frame
To evaluate the safety and efficacy of Extra Moisturizing Baby Soap in study population.Timepoint: Study duration: This study is planned for 8 days	—

Countries

India

Contacts

Public ContactSushma C

The Himalaya Drug Company

dr.palani@himalayawellness.com

Outcome results