Prescription placebos used in research and pra...

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Renovo, a UK company, announced on February 11 that Phase III trials of its lead scar reduction treatment, Juvista (human TGF-beta3) had failed on its primary endpoint (assessment of the scars by independent experts) and on its secondary endpoint (assessment by the patients themselves). The news was even worse as the company is now trying figure out why in some patients, the half of the scar treated with placebo seemed to heal better than the Juvista-treated half.

The REVISE Trial was a double blind, within patient, placebo controlled trial to assess the efficacy of two dose levels of Juvista (200ng and 500ng/100ul/linear cm of wound margin) given twice, following wound closure and 24 hours later, on the appearance of scars following scar revision surgery. Over 350 patients were recruited from 56 centres in UK France, Hungary, Germany, Italy, Poland, Spain, Denmark, Latvia and USA. The EMA agreed primary endpoint for efficacy was a photographic based assessment at 12 months following surgery by an independent panel of experts using the Global Scar Comparison Scale. Secondary endpoints included an assessment of the scars using the Global Scar Comparison Scale by the patients themselves and by the clinical trial investigator. None of the primary or secondary endpoints were met for either dose.

For some additional analysis visit IN VIVO blog.

Surgeon doing a surgical breast biopsy.

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PharmEcosse, a Scottish company, is starting clinical trials to explore the use of insulin (PE001) for the reduction or prevention of surgical scars in patients undergoing non-cancer bilateral breast surgery. The trial will commence in January 2011 and is expected to report in the first quarter of 2013.

Insulin was found to control the activity of the key cells involved in wound closure and subsequent scar formation which apparently slows down or stops the build up of scar tissue.

For more information about taking part in clinical trials, please go to pharmecosse.com

British biopharmaceutical company Renovo announced that its Phase I dose ranging clinical trials designed to establish the safety of Juvista® following the surgical excision of bilateral earlobe keloids met all primary safety objectives. However, due to the insufficient sample size there is no data about efficacy of the product.

Juvista (INN: Avotermin) is a therapeutic application of human recombinant Transforming Growth Factor Beta 3 (TGFβ3). Clinical trials are investigating the effects of intradermal injection of Juvista applied to skin wounds created either by surgical incision or excision, at or shortly after the time of surgery on the appearance of the subsequent scar.