Improvement in Scar Appearance Following Injection of Avotermin (Juvista) Into Skin Incisions Made in Healthy Men and Women
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-centre, double-blind, Placebo-controlled, randomised trial. Trial subjects
      received four 1cm incisional wounds on the inner aspect of each upper arm (eight in total),
      giving four pairs of anatomically matched wound sites per subject. Each subject acted as
      their own control. One site from each anatomical wound pair was randomly treated with
      intradermally administered avotermin (Juvista:100μL per linear cm of wound site
      pre-operatively and 100μL per linear cm of wound margin post-wounding on Day 0 or Day 1,
      400μL per wound site) while the second site was a paired control, treated with Placebo (100μL
      per linear cm of wound site pre-operatively and 100μL per linear cm of wound margin
      post-wounding on Day 0 or Day 1, 400μL per wound site). Wound margins for injection were
      defined as extending 0.5cm from either end of the incision. Four doses of avotermin (Juvista)
      were administered to each subject: 5ng, 50ng, 200ng and 500ng/100μL per linear cm; one dose
      to one wound site per anatomically matched pair of wounds. The second wound site from each
      anatomically matched pair of wounds was dosed with placebo. Allocation of treatment to
      wound-site pairs was randomised and double blinded.

      Primary objective To determine the optimal concentration and dose regimen of Juvista for the
      improvement of the resultant scar when applied to the approximated wound margins of male and
      female subjects following surgical incisions.

      Secondary objective To assess the safety and tolerance of Juvista when applied to the
      approximated wound margins of male and female subjects following surgical incisions.
    


Intervention name(s): Avotermin (Juvista); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intradermal avotermin administered to four wound sites per subject, one wound site per anatomically matched pair, according to the subject's assigned dose group:
Group 1: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 1)
Group 2: avotermin concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site (pre-wounding, Day 0) and 100μL per linear cm of wound margin (post-wounding, Day 0)
Each subject received four doses of active drug at concentrations of 5, 50, 200 and 500ng per 100μL per linear cm of wound site, one dose to one wound site per anatomically matched pair of wounds.; Reference therapy was Placebo (vehicle). On Day 0, the four sites randomised to receive Placebo were administered with a 100μL intradermal injection of Placebo.
Subjects in Group 2 were dosed again on Day 0 at 10 to 30 minutes after wound closure.
Subjects in Group 1 were dosed again on Day 1 at 24 (+/-4) hours after initial administration of drug.
Other intervention name(s): Juvista, RN1001, transforming-growth factor beta 3, TGFβ3
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cicatrix; Scar; TGFβ3; Avotermin; Juvista; RN1001