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Safety assessment of products

Evaluation of irritation potential of skin care and hair care formulation on healthy human subjects - N/AP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037138
Enrollment
24
Registered
2021-10-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: 1) EMC (JLCDLT001): Product A 2) KA-COHC-NPWS 1003 (BG1003): Product B: 1) For product A: Measure 0.04 ml (40 μl) of test sample with the help of a Syringe. Transfer the test product o

Sponsors

Kama Ayurveda Pvt Ltd
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 assessment of productTimepoint: Baseline,0 hrs,24 hrs and 7 days

Secondary

MeasureTime frame
NILTimepoint: N/AP

Countries

India

Contacts

Public ContactMr Mohit Lalvani

Mascot Spincontrol India Pvt. Ltd.

raji@mascotspincontrol.in022-43349191

Outcome results

None listed

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