P290-22 BIO UNDER EYE GEL FOR MEN & WOMEN – Alternates Needed


P290-22 BIO UNDER EYE GEL FOR MEN & WOMEN – Alternates Needed
Posted  September 22, 2022

START DATE10/12/2022
QUALIFICATIONSMen & Women Ages 25 to 65
TIME REQUIREMENT3 Visits
COMPENSATION$250

NOTES: PRESCREENING IS REQUIRED with a clean makeup & product-free face.

  • Subject has mild to moderate visible fine lines and/or wrinkles in the eye area (ages 35-65)
  • Subject has mild to moderate skin roughness around the eye area & mild to moderate puffiness underneath the eye area.
  • Subject must be a regular sunscreen user (minimum SPF 30)
  • No other face studies while on this study.
  • Subject cannot have any skin disorder, irritation, sunburn, scarring, tattoos, cuts, scrapes or abrasion on the test site.
  • Male Subjects must shave 24 to 48 hours prior to study visits.
  • Subject must sign a photography release form.
  • Subjects must be comfortable & able to keep their eyes open during Clarity photos with flash.
  • Masks are optional while at Eurofins|CRL. If you do wear a mask, you must remove it when requested for acclimation & photos.
  • Children are not allowed in the facility for visits 20 minutes or longer.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours:  Visits 1 & 2: 8 a.m. to 12:05 p.m. & 2 to 3:50 p.m.
Visits 1 & 2 will be at the same time.
Visit 3 time will be chosen at Visit 1. Times will be between 8:20 a.m. & 5 p.m. (1st come 1st served).

GROUP 1:
V1:  Pickup & Baseline – Wednesday, 10/12 – 2.5 hours
V2: 
Week 2 – Wednesday, 10/26 – 2.5 hours
V3: 
Week 4 – Thursday, 11/10 – 2.5 hours

GROUP 2:
V1:  Pickup & Baseline – Thursday, 10/13 – 2.5 hours
V2: 
Week 2 – Thursday, 10/27 – 2.5 hours
V3: 
Week 4 – Thursday 11/10 OR Friday 11/11 – 2.5 hours – Date picked at Visit 1 (1st come, 1st served)

GROUP 3:
V1:  Pickup & Baseline – Friday, 10/14 – 2.5 hours
V2: 
Week 2 – Friday, 10/28 – 2.5 hours
V3: 
Week 4 – Friday, 11/11 – 2.5 hours

Inclusion Criteria:
a) Subject is female or male between 25 to 65 years of age;
b) Subject is Fitzpatrick Skin Type I & II (approximately 33% of the population), Fitzpatrick Skin Type III & IV (approximately 33% of the population), Fitzpatrick Skin Type V & VI (approximately 33% of the population)
c) Subject has normal, dry, or combination skin
d) Subjects wear sunscreen of a minimum of SPF 30
e) Subject has mild to moderate visible fine lines and/or wrinkles around the eye area (Subjects 35-65 years of age)
f) Subject has mild to moderate skin roughness around the eye area
g) Subject has mild to moderate puffiness underneath the eye area
h) Male subjects must shave 24-48 hours prior to study visit
i) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
j) Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
k) Subject is willing to participate in all study evaluations;
l) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
m) Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study
n) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
o) Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”

Exclusion Criteria:
a) Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject does not wear sunscreen or can not wear sunscreen
c) Subject has hyperpigmentation around and under the eye area
d) Subject has recently chemically peeled skin or is using chemical peels (in-home or professionally administered)
e) Subject is using prescribed skin care products including oral and topical prescriptions
f) Subject is using OTC or prescription retinoid, benzoyl peroxide, or salicylic acid products
g) Subject has compromised skin barriers due to sunburn, wounds, dermatological, or cosmetic procedures, hair removal, laser treatment, etc.
h) Subject has oily skin affecting the eye area
i) Subject has severe scarring affecting the eye area
j) Subject has severe acne affecting the eye area
k) Subject has atopic dermatitis, keratosis pilaris, psoriasis, eczema, milia affecting the eye area
l) Subject has rosacea around the eye area
m) 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;




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