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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/2018/05/013745
Enrollment
24
Registered
2018-05-07
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: 1. Skin Leave -On (BMEO01) 2. Skin Leave -On (BMEO02) 3. Skin Leave -On (GFEO01) 4. Skin Leave -On (GFEO02) 5. Skin Leave - On (LGEO01) 6. Skin Leave - On (LGEO02) 7. Skin Leave - On

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 scarââ?¬Â¦.) Subjects representing varied skin types (ideally equal representationof all 4 skin types ââ?¬â?? Oily, Normal, Dry and combination)Subjects willing to come for regular follow up and ready to followinstructions 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 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, allergicconjunctivitis 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,T1,T2,T8—

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