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To understand the skin sensitivity of investigational products by assessing the irritation after patch application on human volunteers.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/01/003276
Enrollment
24
Registered
2013-01-01
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)Soap- TSP 61-114. 2)Soap- TSP 65-01. 3)Soap- UTMP. 4)Soap- TSP 61-126. 5)TSP 65-02. 6)Soap- UTSM. : The 40microlitre(after dilution) of each products will be applied in theIQ chambers

Sponsors

ITC RD Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects age group 18 - 55 years • Healthy male & female volunteers • Subjects with skin type III to V. • Subjects willing to give a written informed consent. • Subjects willing to maintain the patch test in position for 24 hours • Subject has not participated in a similar investigation in the past two weeks. • Subjects willing to come for regular follow up. • Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: • Infection, allergy on the tested area • Skin allergy antecedents or atopic subjects • Hyper sensitivity to any component of the tested products • Athletes and subjects with history of excessive sweating • Cutaneous disease which may influence the study result • Chronic illness which may influence the cutaneous state. • Subjects on oral corticosteroid with dose 10mg/day • Subjects participating in any other cosmetic or therapeutic trial. • Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Design outcomes

Primary

MeasureTime frame
To evaluate the dermatological safety of the given investigational product/s on skin of healthy human volunteers by primary irritation patch testTimepoint: 7 days after patch removal.

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Mukta Sachdev

MS Clinical Research Pvt. Ltd,

mukta.sachdev@mscr.in918040917253

Outcome results

None listed

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