Skin Manifestations Clinical Trial
Official title:
Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging
The purpose of this study is to (1) collect trained observer scores and digital images of skin irritated by generic and RLD Lidocaine 5% delivered via TDS, and (2) assess performance of an automated system for predicting scores directly from the digital images
Subjects will be screened prior to dosing to ensure subjects meet all inclusion exclusion
criteria. The test materials will be tested simultaneously. Skin sites on the paraspinal
region will be utilized for application. The test sites will be randomized among the
individual subjects according to their assigned identification number. All patches will be
applied and removed by the laboratory staff.
Due to safety concerns, it is not recommended to simultaneously apply two whole, active,
Lidocaine Patch 5% patches on the same subject during the 21-day period. The optimum design
of this study will depend on the design of the test product patch. Since the RLD has a matrix
design that can be safely cut, one-fourth of the patch can be used for these studies. If the
test product patch also has a design that can be cut to a smaller size, it should also be cut
in one-fourth and one-fourth of the test product patch applied simultaneously with one-fourth
of a RLD patch (to separate skin sites).
Each test article will be applied to sites on the skin for a contact period of approximately
24 hours (+/-1 hr.), with the exception of the weekend (72 hours, +/- 1 hr.). There will be
no visits during the weekend.
Evaluations will be made after removal of every patch by a single trained grader along with a
single digital imaging instrument. Re-applications will be made to the same test sites unless
reactions become so strong (combination of a number and letter grade of 3) as to make this
unadvisable, at which point patch application will be discontinued for that test article.
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