None listed
Conditions
Interventions
Intervention1: Johara Anti hair fall serum: 40 µl without dilution will be pipetted out on the allotted Dermaproof aluminium finn chamber prefixed to a scanpore tape and applied for 24hrs.
Intervent
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subjects in age group 18-65 years both inclusive. 2 Healthy male & female subjects. 3 Subjects with Fitzpatrick skin type III to V. 4 Subjects willing to give a written informed consent. 5 Subjects willing to maintain the patch test in position for 24 hours. 6 Subject having not participated in a similar investigation in the past two weeks. 7 Subjects willing to come for regular follow up visits. 8 Subjects ready to follow instructions during the study period.
Exclusion criteria
Exclusion criteria: 1 Subjects with infection, allergy on the tested area. 2 Subjects with skin allergy, antecedents or atopic subjects. 3 Athletes and subjects with history of excessive sweating. 4 Subjects with any cutaneous disease which may influence the study result. 5 Subjects on oral corticosteroid. 6 Subjects participating in any other cosmetic or therapeutic study. 7 Subject with known allergy or sensitization to medical adhesives, bandages. 8 Subjects who are pregnant or lactating. 9 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 |
|---|---|
| 1] Draize scale for irritation score 2] PhotographsTimepoint: 1] Draize scale for irritation score-Baseline,15 to 30 mins post patch removal,minimum 168 hours post patch removal. 2] Photographs-Baseline and all time points listed above. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment-Adverse and serious adverse event monitoringTimepoint: Safety assessment-Visit 2,Visit 3,visit 4 and Visit 5. | — |
Countries
India
Contacts
Public ContactDr Renuka Jain
Sami Labs Limited
Outcome results
None listed