A trial to compare the efficacy of two formulations of avotermin

• Research type

  Research Study

• Full title

  A double-blind, placebo controlled, randomised trial to compare the efficacy of 250ng and 500ng RN1006 (a new formulation of avotermin) and 250ng and 500ng Juvista (standard avotermin formulation), in the improvement of scar appearance in healthy volunteer subjects

• IRAS ID

  21345

• Eudract number

  2009-011176-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Each year, over one hundred million people undergo elective or emergency surgery and are left with scarring. These types of scars are usually disfiguring, aesthetically unpleasant and can cause complications such as severe itching, tenderness, pain, depression and disruption of daily activities. There is a clinical need for treatments that reduce scarring, as current therapies are often ineffective and inadequate.Results from previous clinical trials show that Juvista (standard avotermin formulation) is effective in improving scars in young and elderly males and females, and concluded that 500ng/100æL/linear cm of wound margin, given twice (24 hours apart) provided optimal efficacy.The availability of a once dosing formulation of avotermin, could have significant benefits over the twice dosing formulation, especially in the paediatric population. Removing the requirement for a second injection within 24h of surgery without reducing the product's efficacy would decrease the stress and discomfort associated with administering the intradermal injection to children.RN1006 has been developed as a stabilised formulation of avotermin, which when dosed in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista, in a human volunteer model.This study is being funded by Renovo Ltd and will recruit 84 healthy volunteer subjects from the Renovo volunteer database, within the UK only. The study is a double-blind, within subject, placebo controlled, randomised trial in male and female subjects. Subjects will be asked to attend a total of 13 visits and will be followed up post-surgery for 12 months.There is no expected direct benefits to trial participants in this study, although knowledge gained may help others in the future.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  09/H0604/65

• Date of REC Opinion

  26 Jun 2009

• REC opinion

  Further Information Favourable Opinion