CTRI/2019/01/017283
Not yet recruiting
未知
A randomized study to determine the Sun Protection Factor of PteroWhite® in female subjects.
Sami Labs Limited0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sami Labs Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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