P084 BIO UNDER EYE CREAM


P084 BIO UNDER EYE CREAM
Posted  May 6, 2021

START DATE05/17/2021
QUALIFICATIONSWomen Ages 25 to 50 - Fitzpatrick Skin types I to IV who are wearers of under eye concealer
FITZPATRICK TYPES1 2 3 4 
TIME REQUIREMENT3 Visits
COMPENSATION$225

NOTES: PRESCREENING IS REQUIRED with a clean, make-up free face.
* Must have moderate vascular undereye symmetrical dark circles
Must be a wearer of under eye concealer
* Must have normal (not sensitive) eyes
* You must wear a face mask/covering while at ECRL except when requested to remove it.
* Children, purses or other personal bags are not permitted in the facility at this time.

Study Hours:  8 am until 5 pm
Group 3:
Visit 1:  Monday, 5/17 – 2 hours
Visit 2:  Monday, 6/14 – 1 1/2 hours
Visit 3:  Monday, 7/12 – 1 1/2 hours

Inclusion Criteria:
1. Subject is a female between 25-50 years of age;
2. Subject has a Fitzpatrick Skin Type I – IV;
3. Subject is any ethnicity, Asian ethnicity up to approximately 20% ;
4. Subject is a contact lens wearer (approximately 25%) and non-contact lens wearer (approximately 75%);
5. Subject must have at least moderate vascular under eye dark circles approximately 50% and pigmented under eye dark circles approximately 50%,
6. Subject must have symmetrical dark circles;
7. Subject must has mild to moderate fine lines and wrinkles in the crows’ feet and periorbital area, lower age range (25-34) may not have wrinkles;
8. Subject must be a wearer of under eye concealer;
9. Subject agrees to avoid the sun, wear a hat when in the sun and wear sunglasses when outdoors;
10. 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;
11. Subject’s best corrected visual acuity is better than 20/200 at the baseline evaluation;
12. Subject reports no subjective ophthalmic irritation at the baseline evaluation;
13. Subject exhibits baseline lacrimation, eyelid, contact lens, and corneal scores of 0. Subject may exhibit slight or mild [level 1 or 2] irritation of the palpebral and/or bulbar conjunctivae at the baseline evaluation. This latitude is permitted to allow for those subjects who normally exhibit slight or mild irritation as a result of their contact lens wear, and/or environmental and seasonal factors;
14. Subject agrees not to introduce any new cosmetic or toiletry products during the study
15. Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits.
16. Subject is willing to participate in all study evaluations.
17. Subject agrees to sign a Model Release Form;
18. Subject is in generally good health and has a current Panelist Profile Form on file at ECRL.
19. Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study.
20. Subject has signed an Informed Consent in conformance with 21 CFR Part 50: “Protection of Human Subjects”;
21. 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 used a dark circle treatment/product/corrector in the past 4 weeks;
3. Subject has sensitive eyes;
4. 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;
5. 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;
6. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
7. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
8. Subject does not exhibit any rashes, scratches or burn marks on the test site (face);
9. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
10. Subject has diabetes.

 




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