P253 Bio Dansyl Chloride #5

P253 Bio Dansyl Chloride #5
Posted  January 9, 2021

START DATE01/26/2021
QUALIFICATIONSFemale 35 to 65 , all skin types

* Study Hours: 9 am through 5 pm
* You must wear a face mask/covering while in ECRL.
*Children, purses and other personal bags are not permitted in the facility at this time.
Visit 1: Pick-up: Tuesday, January  26
Visit 2: Patch Placement, Tuesday, February 9
Visit 3: Patch removal: Wednesday, February 10
Visits 4 through 18: Thursday, February 11 through Friday, March 5 (ECRL will be closed Monday, February 15th)
Inclusion Criteria: Prescreening is required
a) Subject is female (ages above) in general good health.
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; is willing to participate in all study evaluations;
g) Subject agrees to refrain from rigorous exercises and swimming for the 24 hours between patch application
and patch removal.
Exclusion Criteria
a) Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
b) Subject is currently using or has used within one week prior to initiation of the study any systemic or topical corticosteroids, non-steroidal anti-inflammatory agents,, antihistamines, sympathomimetics, and/or vasoconstrictors ;
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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