CTRI/2024/08/073063CompletedPhase 2/3
Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects
Transformative Learning Solution Pvt. Ltd.1 site in 1 country24 target enrollmentStarted: September 9, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- to determine the potential irritation of the test formulation in different skin types in a PIPT test.
Study Overview
Brief Summary
The study consists of single application of sample on the upper back of human participants, under occlusive patch for the duration of 24 hour of exposure. After removal of patches post 24 hr. The assessment of skin reaction needs to be evaluated subjectively using the Draize Scale 24hour removal of patches. Follow up reactions will be done one week thereafter to confirm recovery.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects in age group
- •65 years (both the ages inclusive). Healthy male & female subjects with skin types as defined in the population details under appendix
- •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
- •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.
Outcomes
Primary Outcomes
to determine the potential irritation of the test formulation in different skin types in a PIPT test.
Time Frame: 0Hrs,24hrsand Day7
Secondary Outcomes
- NA(NA)
Investigators
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd
Study Sites (1)
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