CTRI/2021/04/032696
Completed
Phase 2
A randomized study to determine the Sun Protection Factor and UVA protection of Test product in healthy Indian adult subjects - None
ITC Life Sciences Technology Centre0 sites20 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Life Sciences Technology Centre
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subject able to read, understand and sign on informed consent form indicating willingness to participate in the study.
- •2\.Subjects of both genders in age group 18 ââ?¬â?? 55 years (both the ages inclusive).
- •3\.Group A:
- •a.Subjects with ITAÃ?° greater than 28Ã?° determined colorimetrically . (Fitzpatrick skin type will be assessed by dermatologist and recorded for each subject)
- •b.The Average ITA of the subject panel will be attempted to be between 38o to 42 o.
- •c.At least three individuals each in the ITA bands i.e. 28Ã?° to 40Ã?° and 41Ã?° to 55Ã?°
- •d.Subjects with no tanning on any of the test Area.
- •4\.Group B: Subjects of phototype III and IV or Subjects with a colorimetric ITA value in the range of 20\-41o, producing persistent pigmentation darkening to the UVA dose.
- •5\.Both Groups to include Subjects having a clear back with uniform color and no sunburn (erythema), tan, blemishes, cuts, wounds, injuries, allergies, or any other skin condition on the test areas (Upper back region between scapula and waist) that can hamper the assessment.
- •6\.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.
Exclusion Criteria
- •1\.Subjects with sun tan, blemishes, photo\-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the tested area).
- •2\.Subjects allergic to cosmetic products such as moisturizers, creams and body lotion or anything else.
- •3\.Skin allergy antecedents or atopic subjects.
- •4\.Subjects having history of or having active photo dermatitis.
- •5\.Subjects on any known medication for photosensitization. (eg. oral diabetic medications, Sulphur drugs, cancer chemotherapy)
- •6\.Subjects with cutaneous disease which may influence the study result.
- •7\.Subjects on oral corticosteroid in last 2 months.
- •8\.Subjects participating in any other cosmetic or therapeutic study.
- •9\.Subjects who are pregnant or lactating
- •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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