P274-22 BIO DANSYL CHLORIDE #41 ARM STUDY FOR WOMEN


P274-22 BIO DANSYL CHLORIDE #41 ARM STUDY FOR WOMEN
Posted  September 23, 2022

START DATE10/11/2022
QUALIFICATIONSFemales Ages 35 to 65
TIME REQUIREMENT18 Visits
COMPENSATION$175

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

  • Must not have tattoos, excessive hair, scratches or marks 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.
  • 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:
  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.

Visit 1:  Pick-up – Tuesday, 10/11 – 20 minutes
Visit 2:  Patch Application – Tuesday, 10/25 – 15 minutes
Visit 3:  Patch Removal – Wednesday, 10/26- 15 minutes
Visits 4 – 18:  Readings – Thursday, 10/27 to Thursday, 11/16 – 15 minutes

Inclusion Criteria:
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.”

Exclusion Criteria:
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.




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