title: A Multicenter Randomized Controlled Trial Evaluating a Cx43-Mimetic Peptide in Cutaneous Scarring.
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.
authors.affiliation: FirstString Research, Inc., Mount Pleasant, South Carolina, USA.
authors.forename: Christina L
authors.initials: CL
authors.lastname: Grek
authors.affiliation: Virginia Tech Carilion Research Institute, Center for Heart and Regenerative Medicine Research, Roanoke, Virginia, USA; Virginia Tech School of Biomedical Engineering and Sciences, Blacksburg, Virginia, USA.
authors.forename: Jade
authors.initials: J
authors.lastname: Montgomery
authors.affiliation: Paras Hospitals, Gurgaon, Haryana, India.
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Sharma
authors.affiliation: Sri Ramachandra Medical Centre, Sri Ramachandra University, Porur Chennai, Tamil Nadu, India.
authors.forename: A
authors.initials: A
authors.lastname: Ravi
authors.affiliation: Life Line Multispecialty Hospital, Chennai, Tamil Nadu, India.
authors.forename: J S
authors.initials: JS
authors.lastname: Rajkumar
authors.affiliation: Virginia Tech Carilion Research Institute, Center for Heart and Regenerative Medicine Research, Roanoke, Virginia, USA; Virginia Tech School of Biomedical Engineering and Sciences, Blacksburg, Virginia, USA; Department of Emergency Medicine, Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA; Department of Surgery, Division of Plastic Surgery, Carilion Clinic, Roanoke, Virginia, USA.
authors.forename: Kurtis E
authors.initials: KE
authors.lastname: Moyer
authors.affiliation: Virginia Tech Carilion Research Institute, Center for Heart and Regenerative Medicine Research, Roanoke, Virginia, USA; Virginia Tech School of Biomedical Engineering and Sciences, Blacksburg, Virginia, USA; Department of Emergency Medicine, Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Gourdie
authors.affiliation: FirstString Research, Inc., Mount Pleasant, South Carolina, USA. Electronic address: ghatnekar@firststringresearch.com.
authors.forename: Gautam S
authors.initials: GS
authors.lastname: Ghatnekar
mesh_terms: D000328:Adult; D000368:Aged; D002921:Cicatrix / Q000188:drug therapy* / Q000378:metabolism*; D018031:Connexin 43 / Q000737:chemistry* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007249:Inflammation; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D010446:Peptide Fragments / Q000627:therapeutic use*; D010455:Peptides / Q000737:chemistry*; D011446:Prospective Studies; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects*; D013314:Stress, Mechanical; D014945:Wound Healing; D055815:Young Adult
chemical_list: D018031:Connexin 43; D010446:Peptide Fragments; D010455:Peptides; C000621384:aCT1 peptide