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Safety assessment of eye care formulation

Evaluation of irritation potential of Eye Care Formulation on healthy human subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043750
Enrollment
24
Registered
2022-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

None listed

Interventions

Intervention1: Kajal: Product A: The product is leave on product. the product is loaded onto the filter paper disc in the aluminium chambers of the patch and applied on the back of the volunteers at T

Sponsors

TTK Healthcare limited Consumer product division
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, Psoriasis, lichen plan, vitiligo whatever the considered area, Having disorder of the healing (whatever the considered area),Having rhinitis, allergic conjunctivitis or rhinosinusitis

Design outcomes

Primary

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

Secondary

MeasureTime frame
Nil Timepoint: Nil

Countries

India

Contacts

Public ContactMr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

raji@mascotspincontrol.in02243349191

Outcome results

None listed

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