P071-23 BIO FACE MOISTURIZER FOR WOMEN AGES 45 TO 70 – Alternates Needed


P071-23 BIO FACE MOISTURIZER FOR WOMEN AGES 45 TO 70 – Alternates Needed
Posted  January 25, 2023

START DATE02/17/2023
QUALIFICATIONSWomen Ages 45 to 70
FITZPATRICK TYPES1 2 3 4 
TIME REQUIREMENT5 Visits
COMPENSATION$250

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

  • Subject must be Fitzpatrick Skin Type I-IV.
  • Subjects must have the following on a 0-9 scale: uneven skin tone (3-8), dull skin (4-8), skin texture/roughness (3-8), fine lines and wrinkles in crow’s feet and cheeks (3-8), redness (3-8)
  • Subject cannot have visible facial tattoos (including eyeliner, eyebrows, lipliner, etc.)
  • Subject cannot have facial piercings (unless piercings can be removed for all photography)
  • Subject cannot have permanent fake eyelashes
  • Subject cannot have a visible skin disease.
  • Subject cannot be a smoker.
  • Subject cannot have visible sunburn, or planning to vacation with excessive sun exposure or use a tanning booth
  • 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 20 minutes or longer.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours:  8 to 11 a.m. & 1:30 to 3:50 p.m.

GROUP 1:
Visit 1:  Pickup – Friday, 2/17 – 20 minutes
Visit 2:
  Baseline (w/ Lifestyle Images) – Friday, 2/24 – 2 hours
Visit 3:
  Day 3 – Monday, 2/27 – 1.5 hours
Visit 4:  Week 4 (w/ Lifestyle Images) – Friday, 3/24 – 2 hours
Visit 5:  Week 8 (w/ Lifestyle Images) – Friday, 4/21 – 2 hours

GROUP 2:
Visit 1:
  Pickup – Tuesday, 2/21 – 20 minutes
Visit 2:
  Baseline (w/ Lifestyle Images) – Tuesday, 2/28 – 2 hours
Visit 3:
  Day 3 – Friday, 3/3 – 1.5 hours
Visit 4:
  Week 4 (w/ Lifestyle Images) – Tuesday, 3/28 – 2 hours
Visit 5:
  Week 8 (w/ Lifestyle Images) – Tuesday, 4/25 – 2 hours

Inclusions:
• Subject is female between the ages of 45-70 (approximately evenly distributed)
• Subject is Fitzpatrick Skin Type I-IV
• Subjects have the following on a 0-9 scale
• Uneven skin tone (3-8)
• Dull skin (4-8)
• Skin texture/roughness (3-8)
• Fine lines and wrinkles in crow’s feet and cheeks (3-8)
• Redness (3-8)
• Subject agrees not to introduce any new cosmetic or toiletry products during the study
• Subjects will discontinue use of all existing skincare and not use any new skincare products
• Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits
• Subject is willing to participate in all study evaluations
• Subject is in generally good health and has a current Panelist Profile Form on file at ECRL
• Subject agrees to sign a Photography Release and QVC Model Release Form, providing consent for the capture of digital images for use in relation to this clinical study
• Subject agrees to sign a QVC affidavit
• 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.”

Exclusions:
• Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
• Subject has visible facial tattoos (including eyeliner, eyebrows, lipliner, etc.)
• Subject has facial piercings (unless piercings can be removed for all photography)
• Subject has permanent fake eyelashes
• Subject has visible skin disease
• Subject is currently a smoker
• Subject has visible sunburn, or planning to vacation with excessive sun exposure or use a tanning booth
• Subject is engaged in another facial skincare study
• Subject has undergone laser resurfacing or microdermabrasion in the past 6 months
• Subject has undergone a physician administered chemical peel in the past year
• Subject has undergone an injectable cosmetic procedure (Botox®, Restylane®, etc) in the past 6 months
• Subject has undergone a surgical eyelift in their lifetime
• Subject has taken a systemic retinoid in the past 6 months
• Subject has used any skin lightening product within the past month
• Subject has visible acne, atopic dermatitis, eczema, or psoriasis
• Subject has undergone head/neck cosmetic surgery in the past 3 years
• Subject has presence of large scars or large age spots on the face
• 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
• Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
• 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
• Subject exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test site, which might interfere with evaluations of test results
• Subject is currently taking any medications which, in the opinion of the Principal Investigator, may interfere with the study
• Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind
• Subject has diabetes


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