None listed
Conditions
Interventions
Intervention1: PteroWhite® cream: 2 mg/cm2 of PteroWhite® cream will be applied on the assigned test area
Control Intervention1: Untreated control: Exposure to Ultravoilet rays without any applicati
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Subjects in age group 18â??55 years both inclusive. 2 Subjects with Fitzpatrick skin type III and IV. 3 Subjects willing to discontinue the use of soaps and cosmetic products (e.g. creams, moisturizers)in the treatment areas throughout the course of the study. 4 Subjects willing to avoid any exposure of the test area to artificial or natural ultraviolet (UV) light throughout the course of the study. 5 Subjects willing to give a voluntary written informed consent. 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. 9 Subjects with no known abnormal response to sunlight.
Exclusion criteria
Exclusion criteria: 1 Subjects allergic to cosmetic products such as moisturizers, creams and body lotion. 2 Infection, allergy on the tested area. 3 Skin allergy antecedents or atopic subjects. 4 Subjects having history of or having active photo dermatitis. 5 Subjects with cutaneous disease which may influence the study result. 6 Subjects on oral corticosteroid. 7 Subjects participating in any other cosmetic or therapeutic study. 8 Subjects who are pregnant or lactating 9 Subjects with sunburn or sun tan (in the tested area). 10 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] Visual assessment for presence of redness 2] TEWL measurement using TewameterTimepoint: 1] Visual assessment for presence of redness - 16h to 24h after UV radiation. 2] TEWL measurement using Tewameter - 30 seconds at the untreated site, test product and standard site. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1] Safety assessmentTimepoint: 1] Safety assessment - Throughout the study duration. | — |
Countries
India
Contacts
Public ContactDr Renuka Jain
Sami Labs Limited
Outcome results
None listed