Juvista in Scar Revision Surgery of Disfiguring Scars
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is to determine whether Juvista can prevent scar formation or improve the
      appearance of scars following scar revision surgery. The trial will involve comparing Juvista
      to placebo.
    

Detailed description: 
      Each year, over one hundred million people undergo elective or emergency surgery and are left
      with scarring. Of these, over half a million patients undergo scar revision surgery. 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 which
      can lead to a diminished quality of life. There is a clinical need for treatments that reduce
      scarring, as current therapies are often ineffective or inadequate.

      Results from previous clinical trials show that Juvista is effective in improving scars in
      young and elderly males and females. Juvista-treated wounds appear to heal with scars that
      are more similar to the surrounding skin, and are narrower and paler with a faster fading of
      redness compared to placebo and standard care alone. This study will confirm the
      effectiveness of Juvista (avotermin) in the improvement of scar appearance when applied to
      the wound margins of patients following scar revision surgery of disfiguring scars.

      The study is a double blind, within patient, placebo controlled, randomised trial in male and
      female patients. Patients will be asked to attend 10 study visits and will be followed up
      post-surgery for 12 months.

      The potential benefits to the patients taking part in the trial will be that their scar is
      revised by a plastic surgeon. This procedure should leave subjects with a less noticeable
      scar. The existing scar will be surgically removed and the resulting wound will be divided
      into two segments of equal length. In most patients, one segment will receive treatment with
      Juvista administered by intradermal injection, the other with placebo. A few patients will
      receive treatment with Juvista to both segments of the wound.
    

Intervention name(s): Juvista (avotermin); Juvista (avotermin); Juvista (avotermin)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100ng/100µL Juvista administered to each linear centimetre of the margins of one wound segment by intradermal injection immediately after and then 24h after wound closure versus 100μL of placebo administered to each linear centimetre of the margins of the other wound segment by intradermal injection immediately after and then 24h after wound closure; 250ng/100µL Juvista administered to each linear centimetre of the margins of one wound segment by intradermal injection immediately after and then 24h after wound closure versus 100μL of placebo administered to each linear centimetre of the margins of the other wound segment by intradermal injection immediately after and then 24h after wound closure; 250ng/100µL Juvista administered to each linear centimetre of the margins of both wound segments by intradermal injection immediately after and then 24h after wound closure
Other intervention name(s): RN1001, TGFβ3; RN1001, TGFβ3; RN1001, TGFβ3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Scar Revision