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

Evaluation of Dermatological Safety of Investigational Products by Primary Irritation Patch Test on Healthy Human Volunteers of varied skin types. - not applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/03/012314
Enrollment
24
Registered
2018-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

None listed

Interventions

Intervention1: 1. Soap (TSP 108- 165) 2. Soap (TSP 118-01B) 3. Soap (TSP 118-02B) 4. Soap (TSP 118-03B) 5. Soap (TSP 118-04B) 6. Soap (TSP 118-05B) 7. Soap (TSP 118-06B) 8. Soap (TSP 118-07B) 9. Soap

Sponsors

ITC LIMITED ITC Life Sciences and Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) Subjects representing varied skin types (ideally equal representation of all 4 skin types – 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
To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types Timepoint: T0 T30 minutes post patch application T1 T2 T8—

Secondary

MeasureTime frame
not applicableTimepoint: not applicable—

Countries

India

Contacts

Public ContactMr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

mohit@mascotspincontrol.in022-43349191

Outcome results

None listed

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