Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
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
2 other identifiers
interventional
394
1 country
19
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 18, 2017
September 1, 2017
1.2 years
August 11, 2014
September 8, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Mean percent change in inflammatory lesion count from Baseline to Week 12
Week 12
Number of of adverse events
Screening to 12 Weeks
Secondary Outcomes (2)
Mean absolute change in inflammatory lesion count from Baseline to Week 12
Week 12
Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)
Week 12
Study Arms (3)
Sebacia microparticles and laser
EXPERIMENTALGold microparticle suspension + laser treatment x 3 over the course of two weeks
Vehicle suspension and laser
EXPERIMENTALVehicle suspension + laser treatment x 3 over the course of two weeks
Sebacia microparticles without laser
EXPERIMENTALGold microparticle suspension treatment x 3 over the course of two weeks
Interventions
Eligibility Criteria
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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sebacia, Inc.lead
Study Sites (19)
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, 85255, United States
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816, United States
Center for Dermatology & Laser Surgery
Sacramento, California, 95819, United States
Miami Dermatology & Laser Institute
Miami, Florida, 33173, United States
Spencer Dermatology
St. Petersburg, Florida, 33716, United States
Gwinnett Dermatology, PC
Snellville, Georgia, 30078, United States
The Dermatology Institute-DuPage Medical Group
Naperville, Illinois, 60563, United States
Shideler Clinical Research Center
Carmel, Indiana, 46032, United States
Maryland Laser, Skin & Vein Institute
Hunt Valley, Maryland, 21030, United States
Clarkston Skin Research
Clarkston, Michigan, 48346, United States
James Q Del Rosso, DO, LLC
Las Vegas, Nevada, 89144, United States
Skin Laser & Surgery Specialists of NY & NJ
Hackensack, New Jersey, 07601, United States
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067, United States
Dermatology & Laser Center of Charleston
Charleston, South Carolina, 29414, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
Spokane Dermatology Clinic
Spokane, Washington, 92204, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2014
First Posted
August 15, 2014
Study Start
September 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
September 18, 2017
Record last verified: 2017-09