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

Post Marketing Observational Study PMOS to Evaluate the Safety and Efficacy of Creme Cleansing Baby Bar HBCS-011701 On Babies with Atopic Dermatitis Sensitive Skin In 0-36 Months Babies. - NIL

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058788
Enrollment
500
Registered
2023-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: L208- Other atopic dermatitis

Interventions

Intervention1: Crème cleansing baby bar: Crème Cleansing baby bar supports natural lipid balance and prevents dehydration of the babys skin. It has many benefits for the baby’s skin, like provide mild

Sponsors

Himalaya Wellness Company
Lead Sponsor
JSS Medical Research Asia Pacific Private Limited
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To evaluate the safety and efficacy of Test Product in study population.Timepoint: 14 days

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Swathi B

Himalaya Wellness Company

dr.sooryanarayan.h@himalayawellness.com918067549919

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026