Clinical trial NCT02217228: Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
Official title: A Randomized, Prospective, Multicenter, Controlled Study With Blinded Assessment to Determine the Safety and Effectiveness of the Sebacia Acne Treatment System in the Treatment of Inflammatory Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Acne Vulgaris
Lead sponsor: Sebacia, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 394
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

  1. Oral retinoids - 6 months
  2. Other systemic medications - 4 weeks
  3. Topical retinoids, steroids, antibiotics - 2 weeks
  4. OTC topical treatments - 1 week
  5. Light treatments (including IPL or laser), microdermabrasion and/or peels - 8 weeks
  6. Investigational drug, biologic or device - 30 days
  7. 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

Primary outcomes:
measure: Mean percent change in inflammatory lesion count from Baseline to Week 12
timeFrame: Week 12
measure: Number of of adverse events
timeFrame: Screening to 12 Weeks
Secondary outcomes:
measure: Mean absolute change in inflammatory lesion count from Baseline to Week 12
timeFrame: Week 12
measure: Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)
timeFrame: Week 12
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center
state: Arizona
city: Sacramento
country: United States
facility: Laser & Skin Surgery Center of Northern California
state: California
city: Sacramento
country: United States
facility: Center for Dermatology & Laser Surgery
state: California
city: Miami
country: United States
facility: Miami Dermatology & Laser Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Spencer Dermatology
state: Florida
city: Snellville
country: United States
facility: Gwinnett Dermatology, PC
state: Georgia
city: Naperville
country: United States
facility: The Dermatology Institute-DuPage Medical Group
state: Illinois
city: Carmel
country: United States
facility: Shideler Clinical Research Center
state: Indiana
city: Hunt Valley
country: United States
facility: Maryland Laser, Skin & Vein Institute
state: Maryland
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Las Vegas
country: United States
facility: James Q Del Rosso, DO, LLC
state: Nevada
city: Hackensack
country: United States
facility: Skin Laser & Surgery Specialists of NY & NJ
state: New Jersey
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Dermatology & Laser Center of Charleston
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Spokane
country: United States
facility: Spokane Dermatology Clinic
state: Washington
Study officials:
References: