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The Study to check safety of products on human volunteers

Evaluation of irritation potential of Baby Care formulations on healthy minor subjects - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081383
Enrollment
26
Registered
2025-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

None listed

Interventions

Intervention1: Babies Body cream - Super Balm - Multipurpose: A single application of about 0.04ml of product, is applied under occlusion for 24hrs on the subjects back. The patch will keep as it is f

Sponsors

Bespoke Bath (Pure Education Ventures Pvt Ltd)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Girls and Boys Indian subjects. 2) Healthy human subjects 4)Skin is healthy on the studied anatomic unit

Exclusion criteria

Exclusion criteria: 1)Having refused to give his/her assent by not signing the consent form. 2)Taking part in another study liable to interfere with this study. 3) Being diabetic. 4) Being asthmatic. 5) 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). 6)Having cutaneous hypersensitivity (except in the case of studies with evaluation of sensitive skin). 7) Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 8) Having undergone a surgery requiring a general anesthesia of more than one hour in the past 6 months. 9) Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.

Design outcomes

Primary

MeasureTime frame
Dermatological safety / Irritation potential on skinTimepoint: Baseline,0 hrs,24 hrs and 7 days

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

poojayadav@mascotspincontrol.in02243349191

Outcome results

None listed

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