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Baby crème bar study

A clinical study to evaluate the safety and efficacy of HBCS - 011701 on babies with Atopic Dermatitis in the age group 0-36 months â?? Extension study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026901
Enrollment
20
Registered
2020-07-29
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: HBCS - 011701: Wet babyâ??s face and body. Apply the cleansing bar generously, gently work up lather. Rinse thoroughly. Use daily for 15 days Control Intervention1: Not Applicable: N

Sponsors

The Himalaya Drug Company
Lead Sponsor

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. 3. Subjects in general good health as determined from a recent medical history other than atopic dermatitis. 4. Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up. 5. Subjects mother/legal representative, preferably mother willing to abide by and comply with the study protocol. 6. Subjects should not participate in any other clinical study during participation in the current study.

Exclusion criteria

Exclusion criteria: 1. A known history or present condition of an allergic response to any other product that may require medical attention. 2. Chronic illness may influence the cutaneous state. 3. Subjects not willing to stop the use of other baby bath products or soap during the study product.

Design outcomes

Primary

MeasureTime frame
1. Mildness, Gentleness and irritation evaluation by pediatrician 2. Subjective assessment by the subjectâ??s mother/ legal representative on Mildness and gentleness and reduction in symptoms of itching, dryness, redness (Symptoms of atopic dermatitis) 3. Safety assessment of baby skin by local tolerance evaluation 4. Adverse event reporting.Timepoint: Day 01, Day 08 and Day 15

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMs Maheshvari Patel

Cliantha Research

nkpatel@cliantha.com9909013286

Outcome results

None listed

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