Assessing Dermatological Safety. A 24-Hour Patch Test Study on Healthy Individuals Under Complete Occlusion.

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068064

Enrollment

Registered

2024-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: RDZSB2401: 40 microlitre of investigational product with or without dilution (as per the protocol) will be applied back side of the subject. Dose- 40 Microlitre Frequency: once dur

Eligibility

Inclusion criteria

Inclusion criteria: Subjects in age group 18 - 65 years (both the ages inclusive). Healthy male & female subjects. Subjects in good health condition as per the medical screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data. Subject able to read, understand and sign an appropriate informed consent form indicating their willingness to participate. Subjects willing to maintain the patch test in position for 24 hours. Subjects willing to come for regular follow-up visits. Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: Subjects with infection or any skin indications at the test area i.e. back of the subjects. Subjects with known history of skin allergy, antecedents or atopic subjects. Athletes and subjects with history of excessive sweating. Subjects with cutaneous disease which may influence the study result. Subjects on oral corticosteroid. Subjects participating in any other cosmetic or therapeutic trial. Subjects who are pregnant or nursing (self-declared). Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. Subjects working with MSCR.

Design outcomes

Primary

Measure	Time frame
The objective of the study is to determine the potential irritation of the test formulation in different skin types in a PIPT test.Timepoint: Baseline,20-30 minutes,24 hours, Day 7	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Sukrutha S D

MS Clinical Research Pvt. Ltd

dr.sukrutha@msclinical.com7760530477

Outcome results