Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Completed · Not applicable

Conditions studied: Inflammatory Acne Vulgaris

In brief

Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia microparticles with or without laser in the treatment of moderate to moderately-severe inflammatory acne vulgaris

Key facts

Study ID

NCT02217228

Run by

Sebacia, Inc.

People needed

394

Starts

2014-09-01

Expected to finish

2015-12-01

Last updated by the study team

2017-09-18

Who can join

Age: 15 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, 15 - 45 years of age
• Able to provide informed consent/assent; minors will provide assent while parent or legal guardian will provide consent
• Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's Global Assessment
• Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not concentrated in one area
• Subject has Fitzpatrick skin phototype I, II or III
• Subject is in good health, willing to participate and able to comply with protocol requirements

You may not qualify if…

• Severe acne (Investigator's Global Assessment 5) with significant scarring potential and greater than 2 nodular lesions
• Clinically relevant history of keloids
• Facial tattoos
• Acne conglobata, acne fulminans, chloracne, drug-induced acne
• Active concomitant skin disease, excessive scarring or excess facial hair
• Heavily tanned skin; unable or unwilling to avoid tanning beds/excessive sun exposure
• Acne medication and therapy restrictions - time period prior to Baseline (below)
• Oral retinoids - 6 months
• Other systemic medications - 4 weeks
• Topical retinoids, steroids, antibiotics - 2 weeks
• OTC topical treatments - 1 week
• Light treatments (including IPL or laser), microdermabrasion and/or peels - 8 weeks
• Investigational drug, biologic or device - 30 days
• Gold therapy of any type for any reason - EXCLUDED
• Pregnant, lactating, nursing or planning to become pregnant during the study period
• Known allergy to gold, ethanol, diisopropyl adipate, Polysorbate 80
• Clinically relevant condition that makes participation unsafe or that would interfere with study treatment and assessment

Where it is running

• Clear Dermatology & Aesthetics Center — Scottsdale, Arizona, United States
• Laser & Skin Surgery Center of Northern California — Sacramento, California, United States
• Center for Dermatology & Laser Surgery — Sacramento, California, United States
• Miami Dermatology & Laser Institute — Miami, Florida, United States
• Spencer Dermatology — St. Petersburg, Florida, United States
• Gwinnett Dermatology, PC — Snellville, Georgia, United States
• The Dermatology Institute-DuPage Medical Group — Naperville, Illinois, United States
• Shideler Clinical Research Center — Carmel, Indiana, United States
• Maryland Laser, Skin & Vein Institute — Hunt Valley, Maryland, United States
• Clarkston Skin Research — Clarkston, Michigan, United States
• James Q Del Rosso, DO, LLC — Las Vegas, Nevada, United States
• Skin Laser & Surgery Specialists of NY & NJ — Hackensack, New Jersey, United States
• Dermatology, Laser & Vein Specialists of the Carolinas — Charlotte, North Carolina, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Yardley Dermatology Associates — Yardley, Pennsylvania, United States
• Dermatology & Laser Center of Charleston — Charleston, South Carolina, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Austin Institute for Clinical Research — Pflugerville, Texas, United States
• Spokane Dermatology Clinic — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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