None listed
Conditions
Interventions
Intervention1: Product 1 to Product 7 Rinse off
Product 8 to Product 10 Skin Leave - on: For all 10 leave on product, it is placed directly in the aluminum chambers of the patch and applied on the bac
Sponsors
ITC Life Sciences Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects in the age group of 18-55 years(both age inclusive) 2. Subjects with Fitzpatrick skin type III to V 3. Subjects willing to give a voluntary written informed consent 4. Subjects willing to maintain the test patches in designated positions for 24 Hours 5. Subjects having not participated in a similar investigation in the past two weeks 6. Subjects willing to come for regular follow up visits 7. Subjects ready to follow instructions during the study period 8. Subjects without any open wounds, cuts, abrasions, irritation symptoms
Exclusion criteria
Exclusion criteria: 1. Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application 2. Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results 3. Subject is Pregnant or Lactating 4. Athletes and subjects with history of excessive sweating 5. Subjects on oral corticosteroid, or using any topical or systemic medicine which might interfere with the study results 6. Subjects participating in any other cosmetic or therapeutic trial 7. Subjects with 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
| Measure | Time frame |
|---|---|
| Safety assessment of investigational products for irritation potential using Draize scale at 0 hour(30 minutes post patch removal, 24hrs and 7days post patch removalTimepoint: Safety assessment of investigational products for irritation potential using Draize scale at 0 hour(30 minutes post patch removal), 24hrs and 7days (post patch removal) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactRajat Gupta
CIDP Biotech India Pvt Ltd
Outcome results
None listed