Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
NCT ID: NCT02217228
Last Updated: 2017-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
394 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sebacia microparticles and laser
Gold microparticle suspension + laser treatment x 3 over the course of two weeks
Sebacia microparticles and laser
Vehicle suspension and laser
Vehicle suspension + laser treatment x 3 over the course of two weeks
Vehicle suspension and laser
Sebacia microparticles without laser
Gold microparticle suspension treatment x 3 over the course of two weeks
Sebacia microparticles without laser
Interventions
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Sebacia microparticles and laser
Vehicle suspension and laser
Sebacia microparticles without laser
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
35 Years
ALL
No
Sponsors
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Sebacia, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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IDE #G120273
Identifier Type: OTHER
Identifier Source: secondary_id
SEB-0121
Identifier Type: -
Identifier Source: org_study_id