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Safety assessment of test products on skin

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of sensitive skin types

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041217
Enrollment
35
Registered
2022-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Skin Leave-On (132043): Product A: The product is leave on product. So the products is dispensed in the aluminium chambers of the patch and applied on the back of the volunteers at T0 v

Sponsors

ITC LIMITED ITC Life Sciences and Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarââ?¬Â¦.) 2. Subjects representing sensitive skin type and varied skin type (ideally equal representation of all 4 skin types ââ?¬â?? Oily, Normal, Dry and Combination) 3. Subjects willing to come for regular follow up and ready to follow instructions during the study period 4. Subject identified to have sensitive skin basis Dermatologistââ?¬•s assessment of skin with closeness of blood vessels to the surface.

Exclusion criteria

Exclusion criteria: 1. For female : Being pregnant or breastfeeding or having stopped to breastfeed in the past three month. 2. Having refused to give his/her assent by signing the consent form. 3. Taking part in another study liable to interfere with this study 4. Being diabetic,Being asthmatic,Having eczema, oriasis, lichen plan, vitiligo whatever the considered area 5. Having disorder of the healing (whatever the considered area). 6. Having a 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
NILTimepoint: 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