Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects
Condition: Cicatrix; Wound Healing
MeSH terms: Cicatrix; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to further determine the safety and toleration of intradermal
      avotermin (Juvista), confirm accelerated healing and investigate genomic expression profiles
    

Detailed description: 
      Subjects were allocated to two groups. Group 1 had scheduled visits on Day 0, 1, 3 and 4
      while group 2 were scheduled for Day 0, 1, 5 and 6. Follow-up post-trial safety assessments
      were made on Day 10-20.

      On Day 0 each subject received a total of four 1cm incision wounds; two each to the upper,
      inner aspect of each arm. Two areas for incision were marked out on the inner aspect of each
      upper arm and anaesthetised before intradermal injection of Juvista or placebo. One incision
      site on each arm received a dose of 50ng/100μl Juvista and the other incision site received
      Placebo. Following injection a full thickness 1cm incision was made along the marked site.

      On Day 1 all subjects were re-injected with the same dose of Juvista or placebo, 100μl to
      each wound margin (200μl per wound site).

      On Day 3 subjects in Group 1 were re-dosed with 200μl Juvista or Placebo per site (100μl per
      linear cm approximated wound margin) in Arm 1. These sites were then excised with an
      elliptical excision. On Day 4 the same subjects received another dose of Juvista or placebo
      as before.

      Subjects in group 2 received the same treatment to their Arm 1 as those in group 1, except on
      Day 5 and 6.

      All wounds were monitored and photographed at two monthly intervals over the course of 6
      months. At month 6, all incision sites on Arm 2 for both groups were excised.

      All excised wounds were snap frozen for genomic analysis.
    

Intervention name(s): Intradermal avotermin; Intradermal avotermin; Placebo (vehicle); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4; 50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 5 and again on day 6; Placebo administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 3 and again on day 4; 50 ng/100 ul avotermin administered intradermally prior to wounding (day 0) and again 24 h later on day 1. Wounds were dosed again prior to wound excision on day 5 and again on day 6
Other intervention name(s): Juvista; RN1001; TGF beta 3; Juvista; RN1001; TGF beta 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cicatrix; Scar; Avotermin; Juvista; RN1001; TGF beta 3