One treatment of Celotres™, an injectable hydrogel scaffold, may reduce the recurrence of keloid scars, Halscion, Inc. reports.
The study results are slated to be be presented at the South Beach Clinical Dermatology and Aesthetics Symposium on February 17th by Brian Berman, MD, PhD, a voluntary professor of dermatology and cutaneous surgery at the University of Miami Miller School of Medicine and a Halscium, Inc advisor. Celotres is not yet approved by the FDA.
The KLEAR study included 19 patients with 26 earlobe keloids who were treated with Celotres. Celotres was injected into the dermal/subdermal space of the surgical wound post-excision of the existing keloid and prior to final suturing. All subjects returned for their12-month follow-up visits. The keloid recurrence rate at 12 months for subjects treated with Celotres was 19.2% versus 51.2% in the literature.
At the 12 month mark, there were no reports of pain or tenderness, and with one exception, no reported itching. All subjects including those with a keloid recurrence were “totally satisfied” with their outcome. There were also no device-related serious adverse events associated with the use of Celotres.
“The statistically significant difference in the keloid recurrence rate of patients treated with Celotres compared to the literature standard was impressive,” Berman says in a press release. “Celotres has potential to be the first real solution for preventing keloid recurrence in patients that undergo surgical revision for their painful and disfiguring keloids.”