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To test the safety of Baby Cosmetic products by recording the skin reactions after applying 24 hr patch in sensitive skin healthy male and female human subjects.

To assess the mildness of Baby Cosmetic Products marketed by Vishal Mega Mart Pvt. Ltd., using skin irritation test by 24hrs single patch test under complete occlusion on healthy human subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039477
Enrollment
24
Registered
2022-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Yellow Hippo Baby Cream: Will be applied onto designated test sites in the form of Occluded patch and retained till 24 hours Intervention2: Yellow Hippo Baby Hair Oil: Will be applied o

Sponsors

Vishal Mega Mart Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects in the age group 18 - 55 years (both the ages inclusive) 2. Healthy male and female subjects. 3. Subjects with Fitzpatrick skin type III to V. 4. Subjects willing to give written informed consent. 5. Subjects willing to maintain the patch test in position for 24 hours. 6. Subject having not participated in a similar investigation in the past month. 7. Subjects willing to come for regular follow-up visits. 8. Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: 1. Infection, allergy on the tested area. 2. Skin allergy, antecedents, or atopic subjects. 3. Athletes and subjects with a history of excessive sweating. 4. Cutaneous disease which may influence the study result. 5. Subject has used topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment 6. Subjects participating in any other cosmetic or therapeutic study. 7. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Design outcomes

Primary

MeasureTime frame
Skin reactions Erythema (including dryness, scaliness and wrinkles) on a 0-4 point scale and Oedema on another 0-4 points scales per Draize scale.Timepoint: 0 Hr, 24 hr and 7 days of post patch removal.—

Secondary

MeasureTime frame
To assess the Adverse Events if any.Timepoint: 0 to 7 days—

Countries

India

Contacts

Public ContactDr Anand Sachdeva

Basavanagudi Clinic

dermagiri@gmail.com

Outcome results

None listed

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