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Study to evaluate the safety of baby products

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095910
Enrollment
26
Registered
2025-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

None listed

Interventions

Sponsors

Mylo Family (Swara baby products 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)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.

niharika@mascotspincontrol.in02243349191

Outcome results

None listed

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