P138-23 BIO DANSYL ARM TREATMENT #16 (Includes In-House Applications) FOR WOMEN AGES 18 TO 65 – Alternates Needed

NOTES: PRESCREENING IS REQUIRED with clean, product free arms and sleeves that are easy to roll up.

• Subject must not have tattoos at all on forearms.
• Subject must be willing to avoid extended periods of sun exposure for the duration of the study (including artificial tanning).
• Subject must agree to refrain from rigorous exercises and swimming for the 24 hours between patch application and patch removal.
• Subject must not exhibit irritation, excessive hair, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the forearms.
• Subject must not have known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
• Subject must not report a history of allergies to tape adhesives.
• Must not have taken part in a study with the arm as a test site within two weeks of study start.
• Patch Removal must be 24 hours post Patch Application.
• Children are not allowed in the facility for visits longer than 20 minutes.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours:
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

INCLUSION CRITERIA:
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;

EXCLUSION CRITERIA:
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.