A Multicenter Randomized Controlled Trial Evaluating a Cx43-Mimetic Peptide in Cutaneous Scarring

J Invest Dermatol. 2017 Mar;137(3):620-630. doi: 10.1016/j.jid.2016.11.006. Epub 2016 Nov 14.

Abstract

The transmembrane protein Cx43 has key roles in fibrogenic processes including inflammatory signaling and extracellular matrix composition. aCT1 is a Cx43 mimetic peptide that in preclinical studies accelerated wound closure, decreased inflammation and granulation tissue area, and normalized mechanical properties after cutaneous injury. We evaluated the efficacy and safety of aCT1 in the reduction of scar formation in human incisional wounds. In a prospective, multicenter, within-participant controlled trial, patients with bilateral incisional wounds (≥10 mm) after laparoscopic surgery were randomized to receive acute treatment (immediately after wounding and 24 hours later) with an aCT1 gel formulation plus conventional standard of care protocols, involving moisture-retentive occlusive dressing, or standard of care alone. The primary efficacy endpoint was average scarring score using visual analog scales evaluating incision appearance and healing progress over 9 months. There was no significant difference in scar appearance between aCT1- or control-treated incisions after 1 month. At month 9, aCT1-treated incisions showed a 47% improvement in scar scores over controls (Vancouver Scar Scale; P = 0.0045), a significantly higher Global Assessment Scale score (P = 0.0009), and improvements in scar pigmentation, thickness, surface roughness, and mechanical suppleness. Adverse events were similar in both groups. aCT1 has potential to improve scarring outcome after surgery.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Cicatrix / drug therapy*
  • Cicatrix / metabolism*
  • Connexin 43 / chemistry*
  • Connexin 43 / therapeutic use
  • Female
  • Humans
  • Inflammation
  • Laparoscopy
  • Male
  • Middle Aged
  • Patient Safety
  • Peptide Fragments / therapeutic use*
  • Peptides / chemistry*
  • Prospective Studies
  • Severity of Illness Index
  • Skin / drug effects*
  • Stress, Mechanical
  • Wound Healing
  • Young Adult

Substances

  • Connexin 43
  • Peptide Fragments
  • Peptides
  • aCT1 peptide