pvct pg2c2017 - final - 28 nov 2017 · 01*23- 4*156-()&*7 ).() /&3-0'...
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Provectus Protocol PH-10-PS-24 Page 23 of 56 Biopharmaceuticals, Inc. 24 July 2014 CONFIDENTIAL Biopsy specimens should be collected using a 4-6 mm biopsy punch within the plaque margin, as illustrated in Figure 1. Biopsies should be collected from separate sections of the target plaque, from three locations spaced equidistantly around the perimeter.
Figure 1. Illustration of recommended biopsy locations for target plaque. A single biopsy specimen of normal skin will also be collected at baseline (i.e., during screening, at least 7 days prior to first study treatment on Day 1) to establish an immunologic reference for evaluation of psoriatic plaque specimens. Instructions for preparation of biopsy specimens are provided in Appendix E.
5.4 Precautions PH-10 is for topical application to the skin only and should not be ingested. Avoid contact with the eyes; if contact occurs rinse thoroughly with water. There are no specific warnings or precautions associated with the use of PH-10 at the proposed concentrations to be used in the present study. Reported adverse events included occasional mild sensation of burning or tingling or mild bleeding following application of PH-10 to actinic keratosis lesions in conjunction with laser light illumination. Isolated incidents of a severe blister, moderate pruritus and mild tingling or burning sensation have reported among subjects administered PH-10 to psoriatic plaque lesions with and without laser light illumination. Rose bengal is a potential photosensitizer when administered at high concentrations (i.e., 10% rose bengal) so the concurrent use of drugs known to elicit clinically significant risk of
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