Sebacia announced it has completed enrollment in its randomized U.S. clinical trial evaluating the use of its investigational acne treatment system, which uses a combination of gold microparticles and laser treatments.
Sebacia’s gold microparticles are designed to be used with existing dermatologic lasers that heat sebaceous glands and follicles for the treatment of acne in a physician-guided, in-office procedure, according to a press release.
There were 396 people enrolled in the blinded, controlled study to determine safety and effectiveness of the Sebacia Acne Treatment System on inflammatory acne vulgaris. Twenty-eight dermatologists across the United States were involved with the studies, which had parallel assignment of one treatment group and two control cohorts who received either Sebacia microparticles without laser treatment or suspension without Sebacia microparticles in the laser treatment, according to the release.
Mean percent change in inflammatory lesion count from baseline to week 12 and the safety and tolerability of the procedure are the primary outcome measurements. A two-point decrease from baseline investigator’s global assessment will be used as definition of success. While the study accrual is complete, patients will be followed up until December 2015, according to the release.
“We are encouraged by the on-time completion of enrollment,” Anthony Lando, CEO of Sebacia, said in the release. “In December, we expect to finish collecting and unblind the data to perform a full analysis to support our application to the FDA. If approved, Sebacia’s treatment would … create a safe alternative to oral anibiotics and isotretinoin.”