NOTES: DANSYL ARM STUDIES ARE SCHEDULED ON A REGULAR BASIS. CONTACT RECRUITING FOR THE DATES AND TIMES OF THE NEXT STUDY.
PRESCREENING IS REQUIRED FOR YOUR FIRST DANSYL STUDY with clean, product free arms and sleeves that are easy to roll up.
PRESCREENING IS GENERALLY NOT REQUIRED FOR SUBSEQUENT DANSYL STUDIES.
Please read Full General Inclusion and Exclusion Criteria below carefully.
Typical Study Hours:
Visits 1, 2 & 3: 8:30 a.m. to 12 p.m. & 2 to 4:10 p.m.
Visits 4-18: 7:45 a.m. to 5:45 p.m.
Typical Study Schedules:
Visit 1: Pick-up – Mondays or Tuesdays – 20 minutes
Visit 2: (1 day to 2 weeks following Visit 1) – Patch Application – Tuesdays or Wednesdays – 15 minutes
Visit 3: Patch Removal – Wednesdays or Thursdays – 15 minutes
Visits 4 – 18: Readings – all weekdays following patch removal to study end – 15 minutes
General Inclusion Criteria for most Dansyls:
a) Subject is female between 35 and 65 years of age;
b) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
c) Subject is willing to avoid extended periods of sun exposure for the duration of the study (including artificial tanning);
d) Subject agrees to discontinue use of any other soaps, lotions, creams, and sunscreens on the forearm, with the exception of the soap provided for use during the study;
e) Subject is willing to continue with normal washing (with the provided soap) and refrain from the use of washcloths, loofahs, or coarse sponges on test sites;
f) Subject is dependable and able to follow directions as outlined in the protocol;
g) Subject is willing to participate in all study evaluations;
h) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
i) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
j) Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”
General Exclusion Criteria for most Dansyls:
k) Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
l) Subject is currently using or has used in the past week, any systemic or topical corticosteroids, non-steroid anti-inflammatory drugs, antihistamines, sympathomimetics, and /or vasoconstrictors or retinoids or any medication that, in the opinion of the Principal Investigator, may influence the outcome of the study;
m) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
n) Subject has sunburns within the last week or continues use of tanning booths;
o) Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would preclude application of the test material and/or could influence the outcome of the study;
p) Subject has participated in a study involving the arm as a test site within two weeks of study initiation;
q) Subject exhibits irritation, excessive hair, tattoos, sunburn, rashes, scratches, burn marks, scarring, etc. on the test sites, which might interfere with evaluation of test results;
r) Subject reports a history of allergies to tape adhesives;
s) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
t) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
u) Subject has diabetes.