Sebacia has announced completion of enrollment in the U.S. randomized pivotal clinical trial investigating the use of the Sebacia Acne Treatment System, an investigational device that combines gold microparticles and laser energy to target acne. The gold microparticles are designed to be used with existing dermatologic lasers to heat the sebaceous glands and follicles.
The pivotal clinical study is a randomized, blinded, controlled assessment to determine the safety and effectiveness of the Sebacia Acne Treatment System in the treatment of inflammatory acne vulgaris. A total of 396 people were enrolled with 28 leading dermatologists across the United States. The control groups will receive either Sebacia microparticles without laser treatment or the suspension without Sebacia microparticles with laser treatment.
Primary outcome measures are the mean percent change in inflammatory lesion count from baseline to week 12 and the safety and tolerability of the procedure. Secondary outcome measures are the mean absolute change in inflammatory lesion count from baseline to week 12 and success by investigator's global assessment (IGA) at week 12. Success is defined as a two-point decrease from baseline IGA. Although accrual is complete, follow up of participants will continue until December 2015.
“We are encouraged by the on-time completion of enrollment for our pivotal, multi-center, U.S. clinical trial,” said Anthony Lando, CEO of Sebacia. “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 provide dermatologists with an in-office procedure that could eliminate compliance concerns and create a safe alternative to oral antibiotics and isotretinoin.”