NOTES: PRESCREENING IS REQUIRED with a clean makeup & product-free face.
- Subjects must have normal, dry, or combination skin.
- Subjects must wear sunscreen of a minimum of SPF 30 on a daily basis.
- Subjects ages 35+ must have mild to moderate visible fine lines and/or wrinkles.
- Subject must have mild to moderate skin roughness.
- Subject must not have compromised skin barriers due to sunburn, wounds, dermatological, or cosmetic procedures, hair removal, laser treatment, etc.
- Subject must not have severe scarring or severe acne affecting the majority of the face.
- Subject must not have keratosis pilaris, psoriasis, and/or eczema affecting the majority of the face.
- Subject must not have rosacea or melasma.
- 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: 9 to 11:40 a.m. & 2 to 4 p.m.
GROUP 1:
Visit 1: Pickup & Baseline – Wednesday, 4/19 – 2 hours
Visit 2: Week 4 – Wednesday, 5/17 – 1.5 hours
Visit 3: Week 8 – Wednesday, 6/14 – 1.5 hours
GROUP 2:
Visit 1: Pickup & Baseline – Thursday, 4/20 – 2 hours
Visit 2: Week 4 – Thursday, 5/18 – 1.5 hours
Visit 3: Week 8 – Thursday, 6/15 – 1.5 hours
GROUP 3:
Visit 1: Pickup & Baseline – Friday, 4/21 – 2 hours
Visit 2: Week 4 – Friday, 5/19 – 1.5 hours
Visit 3: Week 8 – Friday, 6/16 – 1.5 hours
Inclusions:
a) Subject is female or male between 25 to 60 years of age (approximately 20% ages 25-34 and approximately 80% ages 35-60);
b) Subject is Fitzpatrick Skin Type I and II (approximately 33% of the population), Fitzpatrick Skin Type III and IV (approximately 33% of the population), Fitzpatrick Skin Type V and VI (approximately 33% of the population);
c) Subject has normal, dry, or combination skin;
d) Subject wear sunscreen of a minimum of SPF 30 on a daily basis;
e) Subject has dark spots caused by UV exposure or inflammation (at least 25% of subjects should have visible dark spots);
f) Subject has mild to moderate visible fine lines and/or wrinkles (Subjects 35+ years of age only);
g) Subject has mild to moderate skin roughness;
h) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
i) Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
j) Subject is willing to participate in all study evaluations;
k) Subject is in generally good health and has a current Panelist Profile Form on file at ECRL;
l) Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
m) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
n) Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”
Exclusions:
a) Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject has recently chemically peeled skin or is using chemical peels (in-home or professionally administered);
c) Subject is using prescribed skin care products including oral and topical prescriptions; Subject is using OTC or prescription retinoid, benzoyl peroxide, or salicylic acid products;
d) Subject has compromised skin barriers due to sunburn, wounds, dermatological, or cosmetic procedures, hair removal, laser treatment, etc.;
e) Subject has severe scarring affecting the majority of the face;
f) Subject has severe acne affecting the majority of the face’
g) Subject has keratosis pilaris, psoriasis, and/or eczema affecting the majority of the face;
h) Subject has rosacea;
i) Subject has melasma;
j) Subject does not wear sunscreen or cannot wear sunscreen;
k) Subject spends 70% of their day in direct sun;
l) 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;
m) 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;
n) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
o) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
p) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
q) Subject has diabetes.
Fitzpatrick Scale
