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Assessment of the safety of a cosmetic product on healthy human subjects

Evaluation of the irritation potential of Skin Care Formulation on healthy human subjects having varied skin type - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097799
Enrollment
26
Registered
2025-11-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

None listed

Interventions

Intervention1: Uncap Smooth Anti Acne PM Gel: Patch application as per BIS standard. A Single application of about 0.04ml of product is applied under occlusion for 24hrs on the subjects back. The patc

Sponsors

Alvio Pharmaceuticals Pvt Ltd / UNCAP
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Healthy Human Subjects 2) Skin should be healthy on the studied anatomic unit 3)Subjects representing varied skin types

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/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 anesthesia of more than one hour in the past 6 months. 10) 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