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Safety evaluation of skin care formulation.

Evaluation of irritation potential of Skin Care formulation on healthy human subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045181
Enrollment
26
Registered
2022-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

None listed

Interventions

Intervention1: 10% NIACINAMIDE BODY LOTION: 0μl of test Product is transfer on Aluminium Finn Chamber. The Finn chambers with the loaded products will then be taped onto the back of subjects. This is

Sponsors

MOSAIC WELLNESS PRIVATE LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Healthy Human Subjects 2) is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.). 3) Subjects willing to come for regular follow up and ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three months, Having refused to give his/her assent by signing the consent form, Taking part in another study liable to interfere with this study Being diabetic, Being asthmatic, Having eczema, Poriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having a rhinitis, allergic conjunctivitis or rhinosinusitis

Design outcomes

Primary

MeasureTime frame
Safety / irritation potential of productTimepoint: T0 (before patch application), T1 day (0 hour after the patch removal), T2 days (24 hours after the patch removal), T8 days (1 week after 0 hour of patch removal)

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

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