P038-23 BIO DANSYL CHLORIDE #03 ARM STUDY FOR WOMEN AGES 35 TO 65


P038-23 BIO DANSYL CHLORIDE #03 ARM STUDY FOR WOMEN AGES 35 TO 65
Posted  January 25, 2023

START DATE02/28/2023
QUALIFICATIONSWomen Ages 35 to 65
TIME REQUIREMENT18 Visits
COMPENSATION$195

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)
  • Subject must agree to refrain from rigorous exercises and swimming for the 24 hours between patch application and patch removal.
  • 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.
  • Children 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 5:30 p.m.
Visits 4 – 18: 7:45 a.m. to 5:45 p.m.

Visit 1:  Pick-up – Tuesday, 2/28 – 20 minutes
Visit 2:  Patch Application – Tuesday, 3/14 – 15 minutes
Visit 3:  Patch Removal – Wednesday, 3/15 – 15 minutes
Visits 4 – 18:  Readings – Thursday, 3/16 to Wednesday, 4/5 – 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 duration of the study.
c) Subject agrees to refrain from swimming, sauna, hammam (Turkish bath) for the duration of the study.
d) Subject agrees to refrain from rigorous exercises and swimming for the 24 hours between patch application and patch removal.
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, except for the soap 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 dependable and able to follow directions as outlined in the protocol.
i) Subject is willing to participate in all study evaluations.
j) Subject is in generally good health and has a current Panelist Profile Form on file at CRL.
k) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164.
l) 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 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.
k) Subject is an employee of the Eurofins/CRL laboratory.




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