Sebacia Announces Completion of Enrollment in Pivotal U.S. Clinical Trial for Severe Acne

DULUTH, Ga., Oct. 7, 2015 /PRNewswire/ -- Sebacia, Inc., a company dedicated to delivering breakthrough treatments to advance dermatology, today 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 uses a combination of gold microparticles and laser energy to target acne.

Unlike acne treatments that require daily treatments with lotions or pills, the Sebacia System is intended to treat acne through a simple, physician-guided, in-office procedure.  Sebacia's proprietary gold microparticles are designed to be used with existing dermatologic lasers to heat the sebaceous glands and follicles to treat acne. 

"We are encouraged by the on-time completion of enrollment for our pivotal, multi-center, U.S. clinical trial," said Anthony Lando, Sebacia's CEO. "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."

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 studies were designed as parallel assignment with one treatment group and two control groups. The control groups received 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. 

About Sebacia Microparticles

Made of gold and silica, Sebacia microparticles are specially designed to be activated by the light from commonly used hair removal lasers and are placed in a suspension designed to penetrate the sebaceous follicles. When exposed to a laser pulse, they create a focused photothermal effect in the sebaceous gland and follicle to reduce the number of inflammatory lesions or acne. 

About Sebacia

Sebacia Inc. is a clinical-stage, private medical device company dedicated to creating breakthrough topical therapies for the treatment of dermatological conditions affecting millions of people. Sebacia's goal is to provide a better alternative to the daily use of topical and systemic drugs currently available for the treatment of acne. Sebacia's patented microparticles technology was invented at Rice University, and the proprietary dermatology applications were further developed with researchers from the Wellman Center of Photomedicine at Massachusetts General Hospital. Sebacia is located in Duluth, Georgia.

More information is available at www.sebacia.com or follow us at www.twitter.com/SebaciaNews. 

SOURCE Sebacia, Inc.

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