P040-22 BIO ECZEMA STUDY FOR MEN & WOMEN AGES 18 TO 75 – New Dates Available

P040-22 BIO ECZEMA STUDY FOR MEN & WOMEN AGES 18 TO 75 – New Dates Available
Posted  June 6, 2022

START DATE07/18/2022
QUALIFICATIONSMen & Women Ages 18 to 75

NOTES:  Prescreen required for this study. Please have the area with eczema clean and product free and wear clothing that will allow easy access to that area.
* Subject must have mild to moderate eczema at baseline to enroll in the study.
* Subject cannot be on any other studies for the body.
*  Face masks are now optional at ECRL.
* Children are not permitted in the facility for studies longer than 20 minutes.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours:  9 to 11:00 a.m. and 2 to 4 p.m.

Group 10:
Visit 1:  Pick-up & Baseline – Monday, 7/18 – 1.5 hours
Visit 2:  Day 1 – Tuesday, 7/19 – 1 hour
Visit 3:  Day 3 – Thursday, 7/21 – 1 hour
Visit 4:  Day 7 – Monday, 7/25 – 1 hour

Group 11:
Visit 1:  Pick-up & Baseline – Tueday, 7/26 – 1.5 hours
Visit 2:  Day 1 – Wednesday, 7/27 – 1 hour
Visit 3:  Day 3 – Friday, 7/29 – 1 hour
Visit 4:  Day 7 – Tuesday, 8/2 – 1 hour

Inclusion Criteria:
1. Subject is female or male between 18 and 75 years of age.
2. Subject has mild to moderate eczema.
3. Subject agrees to discontinue use of medications and topical creams used to treat eczema.
4. Subject agrees to remove face mask for the acclimation period (for approximately
15 minutes within socially distanced proximity of other subjects) and for study evaluations (including image captures), and to replace the face mask as directed by study staff;
4. Subject agrees not to introduce any new cosmetic or toiletry products during the study.
5. Subject is willing to use the accessory products and test product provided for the conditioning phase and duration of the study;
6. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
7. Subject is willing to participate in all study evaluations;
8. Subject is willing to refrain from the use of suntan salons and excessive exposure to the sun during the course of the study;
9. Subject is in generally good health and has a current Panelist Profile Form on file at ECRL
10. Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study.
11. Subject has signed an Informed Consent in conformance with 21 CFR Part 50: “Protection of Human Subjects”;
12. Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164.

Exclusion Criteria:
1. Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
2. Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study;
3. Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study;
4. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
5. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
6. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
7. Subject has diabetes.

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