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Clinical trial to check the safety of baby care products

Evaluation of the sensitization potential of Baby Care formulations on healthy human subjects. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094024
Enrollment
220
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

None listed

Interventions

Intervention1: Mother Sparsh Natural Care Baby Wipes With Fresh Cucumber Extract: The product is cut into a 1X1 cm2 area with the help of scissor and transferred to the aluminium chambers of the patch

Sponsors

Mother Sparsh Baby care Pvt. Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit

Exclusion criteria

Exclusion criteria: 1. For female: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2. Having refused to give his or her assent by not signing the consent form 3. Taking part in another study liable to interfere with this study 4. Being diabetic. 5. Being asthmatic. 6. Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). 7. Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). 8. Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 9. Having undergone a surgery requiring a general anaesthesia of more than one hour in the past 6 months. 10. Having changed his or her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. 11. The day of the patch application: no cosmetic product must be used (test site clean with water only).

Design outcomes

Primary

MeasureTime frame
Sensitization potentialTimepoint: Day 3, Day 5, Day 7, Day 10, Day 12, Day 14, Day 17, Day 19, Day 21, Day 38, Day 39, Day 40

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

niharika@mascotspincontrol.in02243349191

Outcome results

None listed

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