P284-22 BIO BRIGHTENING FACE STUDY FOR MEN & WOMEN – Alternates Needed


P284-22 BIO BRIGHTENING FACE STUDY FOR MEN & WOMEN – Alternates Needed
Posted  September 19, 2022

START DATE10/12/2022
QUALIFICATIONSMen & Women Ages 30 to 50
TIME REQUIREMENT3 Visits
COMPENSATION$250

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

  • Subject has dull, uneven skin tone, discoloration, hyperpigmentation, or dark spots on the face
  • Subject has mild to moderate wrinkles, fine lines, and loss of firmness
  • 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.
  • Subject must sign a photography release form. Clarity images.
  • 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:  9:30 a.m. to 12 p.m. & 2 to 4:30 p.m.

GROUP 1: (will keep the same appointment time for all visits)
V1:  Pickup – Wednesday, 10/12 – 30 minutes
V2: 
Baseline – Wednesday, 10/19 – 1.5 hours
V3: 
Week 8 – Wednesday, 12/14 – 1.5 hours

GROUP 2: (will keep the same appointment time for all visits)
V1:  Pickup – Thursday, 10/13 – 30 minutes
V2: 
Baseline – Thursday, 10/20 – 1.5 hours
V3: 
Week 8 – Thursday, 12/15 – 1.5 hours

GROUP 3: (will keep the same appointment time for all visits)
V1:  Pickup – Friday, 10/14 – 30 minutes
V2: 
Baseline – Friday, 10/21 – 1.5 hours
V3: 
Week 8 – Friday, 12/16 – 1.5 hours

Inclusion Criteria:
a) Subject is female or male between 30 to 50 years of age;
b) Subject has dull, uneven skin tone, discoloration, hyperpigmentation, or dark spots on the face
c) Subject has mild to moderate wrinkles, fine lines, and loss of firmness
d) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
e) Subject agrees to wear the provided sunscreen as directed for the duration of the study
f) Subject agrees to use the provided non-moisturizing soap for the conditioning phase of the study;
g) Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
h) Subject is willing to participate in all study evaluations;
i) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
j) Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study
k) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
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 exhibits any skin disorder, sunburn, scarring, tattoos, cuts, scrapes, or abrasions on the test site
c) 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;
d) 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;
e) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
f) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
g) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
h) Subject has diabetes




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