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PATCH TEST ON HEALTHY HUMAN VOLUNTEERS OF VARIED SKIN TYPES

EVALUATION OF DERMATOLOGICAL SAFETY OF INVESTIGATIONAL PRODUCTS BY PRIMARY IRRITATION PATCH TEST ON HEALTHY HUMAN VOLUNTEERS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/004015
Enrollment
24
Registered
2013-09-23
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 ( Sample Code : NRXT 263/1030 ): Patch of formulation was applied onto designated test site and retained till 24 hours. The patch was removed after 24 hours. Intervention2: Pr

Sponsors

Emami Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 • History of skin allergy antecedents or atopic subjects • History of 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 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

Secondary

MeasureTime frame
To gather safety information prior to a pilot study and/or larger study, in order to improve the quality and efficiency of the prospective studiesâ?? design.Timepoint: 9 days for each volunteer (5 visits)

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: 9 days for each volunteer (5 visits)

Countries

India

Contacts

Public ContactDr Harisha S

ICBio Clinical Research Pvt Ltd

harish@icbiocro.com09900111997

Outcome results

None listed

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