P043 BIO DANSYL CHLORIDE #11 ARM STUDY


P043 BIO DANSYL CHLORIDE #11 ARM STUDY
Posted  February 19, 2021

START DATE03/16/2021
QUALIFICATIONSFemale 30 to 65 , all skin types
TIME REQUIREMENT17 visits
COMPENSATION$175

NOTES: PRESCREENING IS REQUIRED
Children, purses and other personal bags are not permitted in the facility at this time.

Study Hours: 8:30 am – 4:00 pm for Visits 1 & 2
Visit 1: Pick-up/ Patch Placement:   Tuesday, March 16
Visit 2: Patch removal: Wednesday, March 17
Visits 3 through 17: Thursday, March 18 through Wednesday, April 7
(Study hours: 8:45 a.m. – 5:30 p.m.)

Inclusion Criteria

  1. Subject is female of any ethnicity between 18 and 50 years of age;
  2. Subject agrees not to introduce any new cosmetic or toiletry products during the study;
  3. Subject agrees to refrain from rigorous exercises and swimming for the 24 hours between patch application and patch removal;
  4. Subject is willing to avoid extended periods of sun exposure for the duration of the study (including artificial tanning);
  5. Subject agrees to discontinue use of any other topical skincare products such as soaps, lotions, creams and sunscreens on the forearm, with the exception of the soap provided for use during the study;
  6. 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;
  7. Subject is dependable and able to follow directions as outlined in the protocol;
  8. Subject must be willing to follow the study requirements and participate in all study evaluations;
  9. Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
  10. Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
  11. Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”
  12. Subject must be able to read and follow study instruction in English;

 Exclusion Criteria

  1. Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
  2. 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 or retinoids or any medication that, in the opinion of the Principal Investigator, may influence the outcome of the study;
  3. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
  4. Sunburn within the last weeks or use of tanning booths;
  5. 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;
  6. Subject has participated in a study involving the arm as a test site within two weeks of study initiation;
  7. 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;
  8. Subject reports a history of allergies to skin marker and/or tape adhesives;
  9. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
  10. Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
  11. Subject has diabetes.



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