NOTES: PRESCREENING IS REQUIRED with clean, product free arms and sleeves that are easy to roll up.
Please read Full Inclusion and Exclusion Criteria below carefully.
Visits 1 – 3: 8:30 to 11:30 a.m. & 2 to 5:30 p.m.
Visits 4 – 26: 7:45 a.m. to 5:45 p.m.
Visit 1: Pick-up – Monday, 6/5 – 30 minutes
Visit 2: Patch Application – Tuesday, 6/6 – 15 minutes
Visit 3: Patch Removal – Wednesday, 6/7- 20 minutes
Visits 4 – 25: Application & Readings – Thursday, 6/8 to Tuesday, 7/11 – 20 minutes
Visit 26: Reading – Wednesday, 7/12- 15 minutes
a) Subject is a female between 18 and 65 years of age;
b) Subject has a Fitzpatrick skin type I-VI (will be recorded and provided in the report);
c) Subject has signed an Informed Consent Form, in compliance with 21 CFR Part 50: “Protection of Human Subjects”;
d) Subject has completed a HIPAA Authorization Form, in conformance with 45 CFR Parts 160 and 164;
f) Subject is in generally good health and has a current Panelist Profile on file;
g) Subject is willing to refrain from the use of tanning salons and will avoid excessive exposure to the sun during the course of the study;
h) Subject is willing to continue with normal washing (with the provided non-moisturizing soap) and refrain from the use of washcloths, loofahs, or coarse sponges on test sites;
i) Subject is willing to refrain from applying any skin treatment products to the forearms, other than the provided test material(s), for the duration of the study;
j) Subject is dependable and able to adhere to the criteria established in the study protocol;
k) Subject agrees to avoid rigorous exercising/swimming on patch day and refrain from getting their patches wet;
a) Subject is currently using any systemic or topical corticosteroids, anti-inflammatory drugs, antihistamines or retinoids or any medication that, in the opinion of the Principal Investigator, may influence the outcome of the study;
b) Subject is pregnant, nursing, planning to become pregnant, or not using adequate birth control;
c) Subject exhibits redness, irritation, sunburn, rashes, scratches, burn marks, scarring or any other marks on the test sites which might interfere with evaluation of test results;
d) Subject has known allergies or sensitivities to any topical products or specific ingredients in products, including cosmetics, toiletries, fragrances, tape adhesives;
e) Subject exhibits excessive hair on the forearms;
f) Subject is currently participating in a study involving the arm as a test site;
g) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
h) Subject has diabetes;
i) Subject has a chronic medical condition that may interfere with testing (e.g. asthma, lupus, rheumatoid arthritis or other immune/auto-immune disease);
j) Subject applies any prescription or over-the-counter medications to skin on the arms;
k) Subject presently takes more than five different prescription medications for medical conditions;
l) Subject has a chronic skin condition (e.g. eczema or psoriasis);
m) Within the past year, subject has had cosmetic medical procedures on the forearms such as cosmetic surgery, tattoo removal, or any other marks on the test sites which might interfere with the evaluation of test results.