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News Breaks | | | | March 14, 2013 | | 08:11 EDT |  | OCLS | Oculus completes patient follow-up in scar management study
Oculus announced completion of the 112-day follow-up period in the company's clinical trial for the management of hypertrophic or keloid scars. The 40-patient comparative, double-blinded and randomized clinical study was based on an FDA-approved protocol. The trial's primary endpoint was to compare a uniquely formulated Microcyn Technology-based hydrogel versus a dimethicone comparator using the Vancouver Scar Scale that measured vascularity, height/thickness, pliability and pigmentation of scars. There were no direct product-related serious adverse events in either arm reported during the study. Secondary endpoints included the measurements of pain and itch and other reported adverse events and treatment satisfaction as reported by patients through a questionnaire. AmDerma/Quinnova has agreed to pay Oculus a milestone payment at the time of the FDA pre-market notification clearance that will reimburse Oculus for the cost of this trial. | |
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News For OCLS From The Last 14 Days Check below for free stories on OCLS the last two weeks. |
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