P107-23-A BIO FACE CREAM STUDY A FOR WOMEN AGES 40 TO 70 – Alternates Needed


P107-23-A BIO FACE CREAM STUDY A FOR WOMEN AGES 40 TO 70 – Alternates Needed
Posted  March 10, 2023

START DATE04/10/2023
QUALIFICATIONSWomen Ages 40 to 70
TIME REQUIREMENT4 Visits
COMPENSATION$250

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

  • Subject must have concerns with firmness, plumpness, roughness, sagging skin, fine lines, and wrinkles/deep wrinkles on the face.
  • Subject must not have visible facial tattoos (including eyeliner, eyebrows, lipliner, etc.).
  • Subject must not have permanent fake eyelashes or eyelash extensions.
  • Subject must not have any known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
  • Subject must not exhibit irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the face.
  • No other face studies while on this study.
  • Subject must sign a photography release form.
  • 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 longer than 20 minutes.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours:  8 to 11:30 a.m. & 2 to 4:30 p.m.

GROUP 1:
Visit 1:  Pickup & Baseline – Monday, 4/10 – 2 hours
Visit 2:
  Week 2 – Monday, 4/24 – 1.5 hours
Visit 3:
  Week 4 – Monday, 5/8 – 1.5 hours
Visit 4:  Week 6 – Monday, 5/22 – 1.5 hours

GROUP 2:
Visit 1: 
Pickup & Baseline – Tuesday, 4/11 – 2 hours
Visit 2: 
Week 2 – Tuesday, 4/25 – 1.5 hours
Visit 3: 
Week 4 – Tuesday, 5/9 – 1.5 hours
Visit 4: 
Week 6 – Tuesday, 5/23 – 1.5 hours

GROUP 3:
Visit 1: 
Pickup & Baseline – Wednesday, 4/12 – 2 hours
Visit 2: 
Week 2 – Wednesday, 4/26 – 1.5 hours
Visit 3: 
Week 4 – Wednesday, 5/10 – 1.5 hours
Visit 4: 
Week 6 – Wednesday, 5/24 – 1.5 hours

Inclusions:
a) Subject is female between the ages of 40-70
b) Subject is any Fitzpatrick Skin Type
c) Subject is Caucasian (Approx. 80% of the study population), Asian (Pacific Rim and Indian Asian – Approx. 10% of the study population), or African American (Approx. 10% of the study population)
d) Subject has concerns with firmness, plumpness, roughness, sagging skin, fine lines, and wrinkles/deep wrinkles on the face
e) Subject agrees not to introduce any new cosmetic or toiletry products during the study
f) Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits
g) Subject is willing to participate in all study evaluations
h) Subject is in generally good health and has a current Panelist Profile Form on file at ECRL
i) Subject agrees to sign a Photography Release, providing consent for the capture of digital images for use in relation to this clinical study
j) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
k) Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”

Exclusions:
a) Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject has visible facial tattoos (including eyeliner, eyebrows, lipliner, etc.)
c) Subject has permanent fake eyelashes or eyelash extensions
d) Subject is currently using or have used in the past week any systemic or topical corticosteroids, nonsteroid anti-inflammatory drugs, antihistamines, sympathomimetics, and/or vasoconstrictors or any medication that, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study
e) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
f) Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, I the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study
g) Subject exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test site, which might interfere with evaluations of test results
h) Subject is currently taking any medications which, in the opinion of the Principal Investigator, may interfere with the study
i) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind
j) Subject has diabetes




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