Posted  September 14, 2021

START DATE09/20/2021
QUALIFICATIONSMen & Women Ages 18 to 70 - cannot have tattoos on forearms
TIME REQUIREMENT3 or 4 Visits - 15 minutes each - 9/20, 9/22, 9/24 and possibly 9/25

* This is a Monday, Tuesday, Wednesday, Friday Study – 3 or 4 visits.
* Panelists only return on Friday if a reaction is observed on Thursday.
* Panelists cannot have any tattoos on the forearm (the test site).
* Panelists will wear the patches on their forearms for 48 hours – patches will be placed on Monday and removed on Wednesday.
* Panelists must wear a mask while in the facility.
* Children, purses or other personal bags are not permitted in the facility at this time.

Study Hours 7:30 a.m. to 6:30 p.m.
Monday 9/20
Wednesday, 9/22
Thursday, 9/23
Friday, 9/25  – Panelists only return on Friday if a reaction is observed.

Inclusion Criteria:
1. Subject is male or female between 18 and 70 years of age;
2. Subject does not exhibit any skin diseases or abnormalities which might be confused with a skin reaction from the test material;
3. Subject agrees to avoid excessive sun exposure of the test sites and to refrain from visits to tanning salons during the course of this study;
4. Subject agrees to refrain from getting patches wet, scrubbing or washing the test area with soap, and applying powders, lotions or personal care products to the area during the course of the study;
5. Subject agrees not to introduce any new cosmetic or toiletry products during the study;
6. Subject is dependable and able to follow directions as outlined in the protocol;
7. Subject is willing to participate in all study evaluations;
8. Subject is in generally good health and has a current Panelist Profile Form and Medical History Form on file at CRL;
9. Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
10. Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: “Protection of Human Subjects.”

Exclusion Criteria:

1. Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
2. 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;
3. Subject has a history of acute or chronic dermatologic (including active eczema or psoriasis on the test sites), medical, and/or physical conditions which would preclude application of the test material and/or could influence the outcome of the study;
4. Subject reports a history of allergies to tape adhesives
5. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
6. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.
7. Subject has a history of skin cancer or is currently undergoing treatment for active cancer of any type
8. Subject is an insulin-dependent diabetic;
9. Subject reports a history of allergies to tape adhesives;

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