NOTES: PRESCREENING IS REQUIRED with a clean makeup & product-free face.
- Subject must be Fitzpatrick Skin Type I-IV.
- Subject must have normal skin.
- Subject must have uneven skin tone, dull skin, skin texture/roughness, fine lines and wrinkles in crow’s feet and cheeks, visible pores, and sagging on the face.
- Subject must not have visible facial tattoos.
- Subject must not have facial piercings.
- Subject must not have permanent fake eyelashes.
- Subject must not have a history of heavy smoking and/or vaping or be a current smoker.
- Subject must not have been on a facial study in the last month.
- Subject must sign a photography release form.
- Children are not allowed in the facility for visits longer than 20 minutes.
Study Hours: 9 to 11:40 a.m. & 2 to 3:40 p.m.
GROUP 1:
Visit 1: Pickup – Monday, 6/19 – 30 minutes
Visit 2: Baseline – Monday, 6/26 – 2 hours
Visit 3: Week 4 – Monday, 7/24 – 1 hour
Visit 4: Week 8 – Monday, 8/21 – 1 hour
GROUP 2:
Visit 1: Pickup – Tuesday, 6/20 – 30 minutes
Visit 2: Baseline – Tuesday, 6/27 – 2 hours
Visit 3: Week 4 – Tuesday, 7/25 – 1 hour
Visit 4: Week 8 – Tuesday, 8/22 – 1 hour
GROUP 3:
Visit 1: Pickup – Wednesday, 6/21 – 30 minutes
Visit 2: Baseline – Wednesday, 6/28 – 2 hours
Visit 3: Week 4 – Wednesday, 7/26 – 1 hour
Visit 4: Week 8 – Wednesday, 8/23 – 1 hour
Inclusions:
a) Subject is female between the ages of 48-70
b) Subject is Fitzpatrick Skin Type I-IV
c) Subject has normal skin
d) Subjects have the following with a minimum score of a 4 on a 0-9 scale: uneven skin tone, dull skin, skin texture/roughness, fine lines and wrinkles in crow’s feet and cheeks, visible pores, and sagging on the face
e) Subjects have a Corneometer score of < 50 a.u.
f) Subject agrees not to introduce any new cosmetic or toiletry products during 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 ECRL
j) 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
k) Subject agrees to sign a QVC affidavit
l) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
m) 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 facial piercings (unless piercings can be removed for all photography)
d) Subject has permanent fake eyelashes
e) Subject has visible skin disease or under the care of a dermatologist for a skin condition
f) Subject has a history of heavy smoking and/or vaping or a current smoker
g) Subject has visible sunburn, or planning to vacation with excessive sun exposure or use a tanning booth or use of a sunless tanner in the test product application area
h) Subject has engaged in another facial skincare study in the last month
i) Subject has undergone laser resurfacing or dermabrasion in the past 2 years
j) Subject has undergone a professionally administered chemical peel or microdermabrasion in the past year
k) Subject has undergone an injectable cosmetic procedure (Botox®, Restylane®, etc) in the past year or plan to have any additional treatments during the study period
l) Subject has taken a systemic retinoid in the past year
m) Subject has used any prescription or OTC skin lightening product or acne products within the past 6 months
n) Subject has visible acne, atopic dermatitis, eczema, or psoriasis
o) Subject has a history of melasma
p) Subject has presence of large scars or large age spots on the face
q) 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
r) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
s) 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
t) Subject exhibits irritation, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test site, which might interfere with evaluations of test results
u) Subject is currently taking any medications which, in the opinion of the Principal Investigator, may interfere with the study
v) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind
w) Subject has diabetes
Fitzpatrick Scale
