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Safety testing of test products under 24 hours patch test.

Evaluation of dermatological safety of investigational products by 24hrs patch test under semi, open and complete occlusion on healthy Indian human participants of varied skin types. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106961
Enrollment
24
Registered
2026-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None listed

Interventions

Intervention1: 16-043D: Product will be in contact with skin for 24 hours under semi-occlusion according to BIS 4011:2018 guidelines Intervention2: 16-043B: Product will be in contact with skin for 24

Sponsors

ITC Life Sciences & Technology Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants in age group 18 - 65 years (both the ages inclusive). 2. Healthy male & female participants with skin types of oily, normal, dry and combination in equal ratios. 3. Participants with Fitzpatrick skin type III to V 4. Participants 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. 5. Participant able to read, understand and sign an appropriate informed consent form indicating her willingness to participate. 6. Participants willing to give a voluntary written informed consent. 7. Participants willing to maintain the patch test in position for 24 hours.

Exclusion criteria

Exclusion criteria: 1. Participants with infection, allergy on the tested area. 2. Participants with skin allergy, antecedents or atopic participants. 3. Athletes and participants with history of excessive sweating. 4. Participants with cutaneous disease which may influence the study result. 5. Participants on oral corticosteroid. 6. Participants participating in any other cosmetic or therapeutic trial. 7. Participants who are currently pregnant or lactating or planning to become pregnant in the period of study. 8. Participants with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. 9. More than one Participant selected/ participating from one family/ household. 10. Participants working with MSCR

Design outcomes

Primary

MeasureTime frame
The objective of the study is to determine the potential irritation of the test formulation in varied skin types in a primary irritation patch test.Timepoint: Day 1, Day 2 and Day 7—

Secondary

MeasureTime frame
NilTimepoint: Nil—

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt. Ltd

ritambhara@msclinical.com08040917253

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026