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To know the safety of Investigational products by assessing the irritation after patch application on healthy human volunteers.

Evaluation of dermatological safety of Investigational Products by Primary Irritation Patch Test on healthy human volunteers of varied skin types.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012902
Enrollment
24
Registered
2018-03-27
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. Deo (534) 2. Skin Leave â?? On(113079) 3. Rinse Off (L8739) 4. Rinse off (89-10) 5. Soap (TSP 108-168) 6. Soap (TSP 108-169) 7. Soap (TSP 108-170) 8. Soap (TSP 108-171) 9. Soap (TSP

Sponsors

ITC LIMITED
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 tobreastfeed in the past three months, Having refused to give his/herassent by signing the consent form,Taking part in another studyliable to interfere with this studyBeing diabetic,Beingasthmatic,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
To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin typesTimepoint: T0 T30 minutes post patch application T1 T2 T8—

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable—

Countries

India

Contacts

Public ContactMr Mohit Lalvani
raji@mascotspincontrol.in022-43349191

Outcome results

None listed

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