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news.Renovo Group's first EU Phase III trial of Juvista in scar revision surgery has failed to meet its primary and secondary endpoints.
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Following the result, Renovo will conduct further exploratory analysis and determine the future of the Juvista development programme.
The double blind, placebo controlled trial was designed to evaluate the efficacy of Juvista on the appearance of scars following scar revision surgery.
The study evaluated two dose levels of Juvista (200ng and 500ng/100ul/linear cm of wound margin) administered twice, following wound closure and 24 hours later.
The study enrolled 350 patients from 56 centres across UK, France, Hungary, Germany, Italy, Poland, Spain, Denmark, Latvia and USA.
The primary endpoint for efficacy was a photographic based evaluation at 12 months following surgery by an independent panel of experts using the Global Scar Comparison Scale.
Secondary endpoints were evaluation of the scars using the Global Scar Comparison Scale by the patients themselves and by the clinical trial investigator.