title: Avotermin for scar improvement following scar revision surgery: a randomized, double-blind, within-patient, placebo-controlled, phase II clinical trial.
abstract: BACKGROUND
  Skin scarring is associated with psychosocial distress and has a negative effect on quality of life. The transforming growth factor (TGF)-β family of cytokines plays a key role in scarring. TGF-β3 improves scar appearance in a range of mammalian species. This study was performed to assess the efficacy of intradermal avotermin (TGF-β3) for the improvement of scar appearance following scar revision surgery.
  
  
  METHODS
  Sixty patients (35 men and 25 women; age, 19 to 78 years; 53 Caucasians; scar length, 5 to 21 cm) received intradermal avotermin (200 ng/100 μl/linear cm wound margin) and placebo to outer wound segments immediately after, and again 24 hours after, complete (group 1) or staged (group 2) scar revision surgery. A within-patient design was chosen to control for interindividual factors that affect scarring. The primary efficacy variable was a total scar score derived from a visual analogue scale, scored by a lay panel from standardized photographs from months 1 through 7 following treatment.
  
  
  RESULTS
  : Primary endpoint data from the combined surgical groups showed that avotermin significantly improved scar appearance compared with placebo (total scar score difference, 21.93 mm; p = 0.04). Profilometry showed a greater reduction in scar surface area from baseline with avotermin treatment compared with placebo, significant in group 2 at months 7 and 12 (difference, 41.99 mm and 25.85 mm, respectively; p = 0.03 for both comparisons). Histologic analysis from group 2 showed that, compared with placebo treatment, collagen organization in avotermin-treated scars more closely resembled normal skin in 14 of 19 cases. Avotermin was well tolerated.
  
  
  CONCLUSIONS
  Avotermin administration following scar revision surgery is well tolerated and significantly improves scar appearance compared with placebo.
  
  
  METHODS
  Therapeutic, I.(Figure is included in full-text article.).
authors.affiliation: Manchester, Leicester, and Belfast, United Kingdom From Renovo, Core Technology Facility; the Department of Plastic and Reconstructive Surgery, the Faculty of Medical and Human Sciences, and the Faculty of Life Sciences, University of Manchester; the Department of Plastic Surgery, Leicester Royal Infirmary; and the Northern Ireland Plastic and Maxillofacial Service, Ulster Hospital.
authors.forename: Karen
authors.initials: K
authors.lastname: So
authors.forename: Duncan A
authors.initials: DA
authors.lastname: McGrouther
authors.forename: James A
authors.initials: JA
authors.lastname: Bush
authors.forename: Piyush
authors.initials: P
authors.lastname: Durani
authors.forename: Lisa
authors.initials: L
authors.lastname: Taylor
authors.forename: Gaynor
authors.initials: G
authors.lastname: Skotny
authors.forename: Tracey
authors.initials: T
authors.lastname: Mason
authors.forename: Anthony
authors.initials: A
authors.lastname: Metcalfe
authors.forename: Sharon
authors.initials: S
authors.lastname: O'Kane
authors.forename: Mark W J
authors.initials: MWJ
authors.lastname: Ferguson
mesh_terms: D000328:Adult; D000368:Aged; D002921:Cicatrix / Q000517:prevention & control* / Q000601:surgery; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012086:Reoperation; D053782:Transforming Growth Factor beta3 / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: C509044:TGFB3 protein, human; D053782:Transforming Growth Factor beta3