Prescreening is required in the BIO Department. Come in anytime to prescreen.
Study Description:
Visit 1/Pick-Up, panelists will report to ECRL with clean product/scratch-free arms. Inclusion and exclusion criteria will be verified and informed consent will be obtained. Subjects will receive soap and choose a new time for patch/unpatch application.
Visit 2/Patch Application, panelists will report to ECRL at their appointment time with clean product/scratch-free arms. Please shower before arrival as the patches cannot get wet after application. 2 Patches with Dansyl Chloride will be put on the volar surface of the forearms.
Visit 3/Patch Removal, panelists will report to ECRL (24 hours from the time they were patched) with the 2 patches intact. The patches will be removed, and the sites will be examined and graded for the presence of fluorescence using a Wood’s Lamp. Photos will be taken and product will be applied. Subjects will then return AT LEAST 4 hours after their first appointment for their second application.
Visits 4-18, Panelists are required to return to ECRL for forearm evaluation under the Wood’s Lamp Monday – Friday TWICE A DAY. Subjects must come for their first reading and product application between 7:45am-1:00pm. They will then come back AT LEAST 4 hours later for their second product application, no later than 5:45 pm. Photos will be taken on 10/16, 10/21, 10/23, and 11/6
Inclusion Criteria
- Subject is female between the ages of 18-65;
- Subject is of any ethnicity;
- Subject is of any skin type;
- Subject is Fitzpatrick Skin Type I-VI (to be recorded) with equal representation;
- Subject agrees not to introduce any new cosmetic or toiletry products during the study other than the products provided in this study;
- 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;
- Subject is willing to avoid extended periods of sun exposure for the duration of the study (including artificial tanning);
- 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;
- 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;
- Subject is willing to cleanse the forearms with the provided soap at least 30 minutes prior to every visit
- Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits
- Subject is willing to participate in all study evaluations
- Subject is in generally good health and has a current Panelist Profile Form on file at ECRL
- Subject agrees to sign a Photography Release, providing consent for the capture of digital images for use in relation to this clinical study
- Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
- Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”
- Subjects must be able to read and follow study instructions in English.
Exclusion Criteria
- Subject has participated in a study involving the arm as a test site within two weeks of study initiation;
- Subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control.
- Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study;
- Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would, in the opinion of the Principal Investigator, preclude application of the test material and/or could influence the outcome of the study;
- Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
- Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs;
- Subject exhibits any tattoos, rashes, scratches or burn marks on the test site (arm) which may interfere with the evaluation of the test sites/results at the discretion of the principal investigator;
- Subject has had a sunburn within the last week or uses tanning booths;
- Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind;
- 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;
- Subject has diabetes.
Visit 1: P/U 20 mins Monday, October 14
Visit 2: Patch 20 mins Tuesday, October 15
Visit 3: Unpatch 30 mins Wednesday, October 16
Day 0-21 20 mins Thursday, October 17 – Wednesday, November 11
*Photos 10/16, 10/21, 10/23, and 11/6*
Call our Recruiting Department for more information.
Fitzpatrick Scale
