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24hrs skin sensitivity patch test on healthy human volunteers.

Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009239
Enrollment
24
Registered
2017-08-02
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: 5 product oil, 1 product gel: The 40 micro liter(After dilution for respective products as per EC Approved protocol)of each products will be loaded in IQ chambers and same will be paste

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Subjects in age group 18 - 55 years • Healthy male & female subjects • Subjects with Fitzpatrick 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 having not participated in a similar investigation in the past two weeks. • Subjects willing to come for regular follow up visits. • 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 • Subjects participating in any other cosmetic or therapeutic study. • 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
The objective of this study is to evaluate the dermatological safety of the investigational products on healthy human subjectsTimepoint: 0hr,24hr and 7days post patch removal

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Mukesh Ramnane

MS Clinical Research Pvt.Ltd.

mukesh.ramnane@mscr.in08040917253

Outcome results

None listed

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