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

To evaluate the irritation potential of Skin Care formulation on healthy human subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003192
Enrollment
24
Registered
2012-12-07
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.Soap (TSP 67 -032) 2.Soap (TSP 67 -030) 3.Soap (TSP 67 -035) 4.Soap (TSP 66 -079) 5.Soap (TSP 66 -080) 6.Soap (TSP 19 -079) : 1.The product is diluted 8% and solution is dispensed in

Sponsors

ITC RD CENTRE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy subjects Between 18 and 50 years of age Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarââ?¬Â¦.) Subjects representing varied skin types (ideally equal representation of all 4 skin types ââ?¬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, psoriasis, 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 (before patch application, T1(0 hours after patch removal), T2(24 hours of patch removal), T8 (T+1 week after 0 hours of patch removal—

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable—

Countries

India

Contacts

Public ContactDr Mary Francis

MASCOT-SPINCONTROL India Pvt. Ltd.

mary@mascotspincontrol.in022-43349191

Outcome results

None listed

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