Investigation Into the Scar Reduction Potential of Prevascar (Interleukin-10)
Condition: Cicatrix; Wound Healing
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to investigate the scar-reducing properties of eight doses of
      intradermal Prevascar (IL-10).
    

Detailed description: 
      Subjects were randomised to one of two dose groups, each with four concentrations of
      intradermal Prevascar. Subjects had four 1cm incisional wounds made on the inner aspect of
      each upper arm (eight in total), giving four sets of anatomically paired wound sites per
      subject. Each subject acted as their own control with one site from each wound pair randomly
      treated with intradermal Prevascar and the other treated with Placebo (vehicle) or Standard
      Care.

      Intradermal Prevascar was administered at 100μl per linear cm of wound site prior to wounding
      on Day 0 and 100μl per linear cm to each wound margin 24 hours later on Day 1. Group 1
      subjects received doses of 5, 50, 250 and 1000ng/100μl and group 2 subjects received 25, 125,
      500 and 2000ng/100μl.

      Subjects in each group were also randomised into two control subgroups to receive either
      100μl/linear cm intradermal placebo (Subgroup 1) or Standard Care alone (Subgroup 2) at
      control wound sites.

      Subjects returned for follow-up at Day 14, Month 1, Month 3, Month 6, Month 9 and Month 12.
    

Intervention name(s): Prevascar; Prevascar; Prevascar; Prevascar; Prevascar; Prevascar; Prevascar; Prevascar; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intradermal Prevascar, 5ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later; Intradermal Prevascar, 50ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later; Intradermal Prevascar, 250ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later; Intradermal Prevascar, 1000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later; Intradermal Prevascar, 25ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later; Intradermal Prevascar, 125ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later; Intradermal Prevascar, 500ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later; Intradermal Prevascar, 2000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later; Intradermal Placebo, 100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later
Other intervention name(s): IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cicatrix; Scar; Wound-healing; Prevascar; Interleukin-10 (IL-10); Ilodecakin; RN1003