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Assessment of irritation potential of skin products

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/2019/08/020666
Enrollment
24
Registered
2019-08-09
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: Oryza cream(TR001): Intervention 1.Oryza Cream(TR001) The product is leave on, so placed directly in the aluminum chambers of the patch and applied on the back of the volunteer.

Sponsors

Alembic Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarâ?¦.) Subjects representing varied skin types (ideally equal representation of all 4 skin types â?? Oily, Normal, Dry and combination) 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, oriasis, 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 productsTimepoint: Safety assessment of products

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMr Mohit Lalvani

Mascot-Spincontrol India Pvt. Ltd.

siddheshwar@mascotspincontrol.in022-43349191

Outcome results

None listed

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