CTRI/2023/02/049856Completed未知
A randomized study to determine the Sun Protection Factor of Test product in healthy adult participants
nilever Industries Pvt Ltd0 sites10 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Participant able to read, understand and sign on informed consent form indicating willingness to participate in the study.
- •2. Participants of either male or female gender in age group 18 – 55 years (both the ages inclusive).
- •3. Test participants shall have an ITA° value of at least 28° by colorimetric methods and be untanned on the test area (i.e., back)
- •4. The average of the participants making up a test panel shall have an ITA° between 41° and 55°. [When possible, there should be participants with ITA°s in each of the three ITA° bands, 28° to 40°, 41° to 55°, and >56°. Where this is not possible, there shall be at least three individuals in each of two of the three ITA° bands described in the previous sentence].
- •5. The test sites intended for UV exposure shall be free from blemishes and hair, and have an even colour tone with no variation in ITA° greater than 5° from each other or the MEDu test area
- •6. Participants willing to discontinue the use of soaps and cosmetic products (e.g. creams, moisturizers) in the treatment areas throughout the course of the study.
- •7. Participant willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.
- •8. Participants willing to adhere and comply to the study protocol, procedure, restrictions and vising the study site for follow up visits at the specified date and time.
- •9. Participants with no known abnormal response to sunlight.
- •10. Participants willing and capable to follow the study rules and a fixed schedule.
Exclusion Criteria
- •Participants showing COVID symptoms (cold, cough, fever, fatigue, headache, diarrhea, difficulty in breathing)
- •Participants who do not qualify on the thermal screening (body temperature higher than 37.5oC) or report to the study site without appropriate mask.
- •If any household member is positive (self-reported by the participants) within the 10 days prior to screening or during the study, then the participant will be withdrawn from the study.
- •Participants who disagree to follow the COVID safety protocol during the study.
- •Participants who have travelled outside the state (current interstate travel regulation) in the last 10 days and do not have negative RT-PCR report issued in last 72 hours
- •1. Participants with sun tan, blemishes, photo-toxicity reactions, cuts, abrasions, wounds, injuries, allergic reactions (in the tested area).
- •2. Participants allergic to cosmetic products such as moisturizers, creams and body lotion or anything else.
- •3. Skin allergy antecedents or atopic participants.
- •4. Participants having history of or having active photo dermatitis.
- •5. Participants on any known medication for photosensitization. (e.g., oral diabetic medications, Sulphur drugs, cancer chemotherapy)
- •6. Participants with cutaneous disease which may influence the study result.
- •7. Participants on oral corticosteroid in last 2 months.
- •8. Participants participating in any other cosmetic or therapeutic study.
- •9. Participants who are pregnant or lactating
- •10. Participants with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
- •11. Participants who have participated in a similar investigation in the past 8 weeks.
- •12. Participants who are currently an employee of MSCR or Unilever
Investigators
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