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Repeat closed patch test study to evaluate the irritation test materials by repeated insult patch test method by pasting patch on the upper back of healthy human subjects.

A negative controlled, repeat closed patch test study to evaluate the irritation and /or sensitization potential of test materials by repeated insult patch test method under occlusion over the skin of healthy human subjects. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003233
Enrollment
50
Registered
2012-12-18
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: Sensitive Sunscreen: 25micro liter of product applied on Upper back of volunteers Intervention2: Aqua Rush Cream with perfume: 25micro liter of product applied on Upper back of voluntee

Sponsors

KAYA Limited
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 as directed. Subject has not participated in a similar investigation in the past four weeks. Subjects willing to come for regular follow up and patch application visits. Subjects ready to follow instructions during the study period

Exclusion criteria

Exclusion criteria: Skin allergy antecedents or atopic subjects Hypersensitivity 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 determine the irritation and/or sensitization potential of a test material(s) under occlusionTimepoint: To determine the irritation and/or sensitization potential of a test material(s) under occlusion—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Mukta Sachdev

MS Clinical Research Pvt Ltd

mukta.sachdev@mscr.in91-80-40917253

Outcome results

None listed

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