P045 BIO DANSYL #13 ARM STUDY FOR WOMEN


P045 BIO DANSYL #13 ARM STUDY FOR WOMEN
Posted  May 6, 2021

START DATE05/11/2021
QUALIFICATIONSWomen Ages 18 to 65
TIME REQUIREMENT18 Visits
COMPENSATION$225

NOTES: PRESCREENING IS REQUIRED
* No other studies while on this study.
*Study hours: Pick-up – 8:40 am to 4:20 pm
*Patch Application (V2) and Patch Removal (V3) must be the same time
* You must wear a mask while in the facility.
*Children, purses or other personal bags are not permitted in the facility at this time.

Visit 1:  Pick-up – Tuesday, 5/11 (8:40 am to 4:20 pm): 30 minutes
Visit 2: Patch Application – Tuesday, 5/25 (8:40 am to 5 pm): 30 minutes
Visit 3: Patch Removal – Wednesday, 5/26 (8:40 am to 5 p.m.: 30 minutes
Visits 4 – 18: Readings – 5/26 to 6/17 (8 a.m. to 5:30 p.m.) – 15 minutes

Inclusion Criteria:
a. Subject is female between 18 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.”

Exclusions:
a. Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b. 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;
c. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
d. 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;
e. Subject has participated in a study involving the arm as a test site within two weeks of study initiation;
f. 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;
g. Subject reports a history of allergies to tape adhesives;
h. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
i. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
j. Subject has diabetes.


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