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24 hrs primary irritation patch test on healthy human volunteers

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/05/003638
Enrollment
24
Registered
2013-05-14
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: Product 1-ZB-64 Product 2-ZB-87 Product 3-ZB-94 Product 4-MPB-22 : The 40 microliterof each products will be loaded in IQ Chambers of patch and the same will be pasted on upper back of

Sponsors

Emami ltd
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 test site • 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, hypertension, liver disease or history of alcoholism, HIV or any other serious medical illness.

Design outcomes

Primary

MeasureTime frame
The objective of this study is to evaluate the dermatological safety of the given investigational products on healthy human volunteers.Timepoint: The objective of this study is to evaluate the dermatological safety of the given investigational products on healthy human volunteers.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Mukesh Ramnane

MS Clinical Research Pvt.Ltd

mukesh.ramnane@mscr.in918040917253

Outcome results

None listed

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