P308-22 BIO DANSYL CHLORIDE #50 ARM STUDY w/photos FOR WOMEN


P308-22 BIO DANSYL CHLORIDE #50 ARM STUDY w/photos FOR WOMEN
Posted  November 18, 2022

START DATE12/05/2022
QUALIFICATIONSFemales Ages 18 to 65
TIME REQUIREMENT18 Visits
COMPENSATION$200

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

  • Must not have excessive hair, scratches, marks of any tattoos, on the volar surface of the forearms.
  • Subject is willing to avoid extended periods of sun exposure for the duration of the study (including artificial tanning)
  • 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.
  • Visits 3, 8 and 18 will be 30 minutes & include digital photography.
  • Subject is willing to sign a photography release.
  • Face masks/coverings while at ECRL are optional.
  • Children (unless they are participating in a study) are not allowed at ECRL for visits that are 20 minutes or longer.

Please read Full Inclusion and Exclusion Criteria below carefully.

Study Hours:
Visits 1, 2, 3:
  9 a.m. to 12 p.m. & 2 to 5:30 p.m.
Visits 8 & 18:  9 a.m. to 5:45 p.m.
All other visits: 7:30 a.m. to 5:45 p.m.

Visit 1:  Pick-up – Monday, 12/5 – 30 minutes
Visit 2:  Patch Application – Tuesday, 12/6 – 15 minutes
Visit 3:  Patch Removal w/ digital photography – Wednesday, 12/7- 30 minutes
Visits 4 – 7:  Readings – Thursday, 12/8 to Tuesday, 12/13 – 15 minutes
Visit 8:  Reading w/ digital photography – Wednesday, 12/14- 30 minutes
Visits 9 – 17:  Readings – Thursday, 12/15 to Wednesday, 12/28 – 15 minutes
Visit 18:  Reading w/ digital photography – Thursday, 12/29- 30 minutes

INCLUSION CRITERIA:
a) Subject is female between 18-65 years old
d) Subject agrees not to introduce any new cosmetic or toiletry products during the study;
e) Subject is willing to avoid extended periods of sun exposure for the duration of the study (including artificial tanning);
f) Subject agrees to discontinue use of any other soaps, lotions, creams and sunscreens on the forearm, with the exception of the soap and the test material provided for use during the study;
g) 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;
h) Subject is willing to sign a photography release form and have photos of the forearms taken;
i) Subject agrees to refrain from getting their patches wet for 24 hours prior to the removal visit and refrain from rigorous exercise and swimming during that period;
j) Subject is dependable and able to follow directions as outlined in the protocol;
k) Subject is willing to participate in all study evaluations;
l) Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
m) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
n) Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”

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, 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.




Sign up today!