None listed
Conditions
Interventions
Intervention1: Plastic disc from device (non-sterile): Plastic dis extracted from device
Intervention2: Extractant of entire sterile device in Saline: 250 microlitre of investigational
product
(as
Sponsors
Nelson Torres
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects in age group 18 - 65 years (both the ages inclusive). 2. Healthy male & female subjects (at least one third of either sex) 3. Subjects in good health condition as per the health screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of the data. 4. Subject able to read, understand and sign an appropriate informed consent form indicating their willingness to participate. 5. Subjects willing to maintain the patch test in position for the required duration. 6. Subjects willing to come for regular follow-up visits. 7. Subjects with a broad upper back. 8. Subjects ready to follow instructions during the study period.
Exclusion criteria
Exclusion criteria: 1. Subjects with known history of clotting or bleeding disorder such as hemophilia(self- declared) . 2. Subjects with skin allergy, antecedents or atopic subjects. 3. Athletes and subjects with history of excessive sweating. 4. Subjects who is immunodeficient or immunosuppressed due to medical condition or medication 5. Subjects taking anticoagulant therapies or low dose aspirin(self-declared). 6. Subjects with known sensitivity to the test material or showing any signs of dermatitis. 7. Subjects prone to actinic keratoses and keloid scars. 8. Any systemic infection or disease that may affect the study as per PI ‘s discretion, such as diabetes or cancer. 9. Subjects with cutaneous disease or skin infection, or damage at the site of application which may influence the study result. 10. Subjects on oral corticosteroid or any other medication that may impact the study results 11. Subjects who are currently pregnant or lactating or planning to become pregnant in the period of study (self-declared). 12. Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness. 13. More than one subject selected/participating from one family/household. 14. Subjects who are employees of MSCR or sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective The objective of the study is to determine the irritation potential of the test materials by a sequential patch test.Timepoint: 15 min,30 min,1hour,2 hour,3 hour,4 hour,24 hour. | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactRadha S
MS Clinical Research Pvt. Ltd
Outcome results
None listed