A study to determine the protection factor of a test product against sun rays.

Phase 2

Completed

• Registration Number: CTRI/2021/04/032696
• Lead Sponsor: ITC Life Sciences Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-17
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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 ITA�° greater than 28�° 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. 28�° to 40�° and 41�° to 55�°

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.

7.Subject willing to avoid any exposure of the test area to artificial or natural Ultraviolet (UV) light throughout the course of the study.

8.Subjects willing to adhere to the study procedure, restrictions and vising the study site for follow up visits at the specified date and time.

9.Subjects with no known abnormal response to sunlight.

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.

11.Subjects who have participated in a similar investigation in the past two weeks.

12.Subjects who are currently an employee of MSCR or the sponsor

Study & Design

• Study Type: Interventional
• Study Design: Not specified