- PRESCREEN REQUIRED FOR THIS STUDY with a clean product and make-up free face.
- Subjects must have rosacea with inflammatory symptoms such as (1) burning and /or stinging, or (2) pustules
- Subjects cannot use any products to treat rosacea for the 14 days prior to the start of the study.
- Subjects will be chosen randomly for Lifestyle Video Testimony – those chosen will be paid $300. Must be okay with doing the filmed interview.
- Subjects not having Lifestyle photos/video will be paid $225
- No other studies for the Face or Hair while on this study.
- Face masks are optional while at Eurofins|CRL. If wearing a mask, you must remove it when requested for acclimation and photos.
- Children are not permitted in the facility for studies 20 minutes or greater.
Please read all Inclusion & Exclusion criteria below.
Study Hours: 8 – 11:45 a.m. & 1:25 to 3:05 p.m.
GROUP 6:
Visit 1: Pickup – Thursday, 5/26 – 20 Minutes
Visit 2: Baseline – Friday, 6/10 – 2.5 Hours
Visit 3: Day 3 – Monday, 6/13 – 1.5 Hours
Visit 4: Day 7- Friday, 6/17 – 1.5 Hours
Visit 5: Day 14 – Friday, 6/24 – 2 Hours
Visit 6: Day 28 – Friday, 7/8 – 2.5 Hours
Inclusions
a) Subject is male or female between 20 and 65 years of age;
b) Subject is Fitzpatrick I-IV;
c) Subject agrees to remove face mask for the acclimation period and study;
d) Subject is of any ethnicity;
e) Subject has normal, oily, dry or combination skin type and normal or sensitive skin;
f) Subject presents rosacea with inflammatory symptoms such as: (1) burning and/or stinging, or (2) pustules as determined by the Principal Investigator;
g) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
h) Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
i) Subject is willing to participate in all study evaluations;
j) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
k) Subject agrees to sign a Photography Release Form, providing consent for the capture of digital images for use in relation to this clinical study;
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) Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject cannot use any product to treat rosacea for the 14 days prior to beginning this study, including antibiotics or corticosteroids;
c) 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;
d) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
e) Subject has used any product to treat rosacea for the 14 days prior to beginning this study, including antibiotics or corticosteroids;
f) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
g) Subject is participating in another clinical trial involving the same test areas, and oral, injectable or other drug trials with systemic implications;
h) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
Fitzpatrick Scale
