Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Not Applicable

Completed

Conditions: Inflammatory Acne Vulgaris

Interventions: Device: Vehicle suspension and laser
Device: Sebacia microparticles and laser
Device: Sebacia microparticles without laser

Registration Number: NCT02217228

Lead Sponsor: Sebacia, Inc.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 394

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle suspension and laser	Vehicle suspension and laser	Vehicle suspension + laser treatment x 3 over the course of two weeks
Sebacia microparticles and laser	Sebacia microparticles and laser	Gold microparticle suspension + laser treatment x 3 over the course of two weeks
Sebacia microparticles without laser	Sebacia microparticles without laser	Gold microparticle suspension treatment x 3 over the course of two weeks

Primary Outcome Measures

Name	Time	Method
Mean percent change in inflammatory lesion count from Baseline to Week 12	Week 12
Number of of adverse events	Screening to 12 Weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19): 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
🇺🇸
Saint 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
Clarkston Skin Research
🇺🇸
Clarkston, Michigan, 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
Spokane Dermatology Clinic
🇺🇸
Spokane, Washington, United States
James Q Del Rosso, DO, LLC
🇺🇸
Las Vegas, Nevada, United States
Tennessee Clinical Research Center
🇺🇸
Nashville, Tennessee, United States
Clear Dermatology & Aesthetics Center
🇺🇸
Scottsdale, Arizona, United States
Dermatology & Laser Center of Charleston
🇺🇸
Charleston, South Carolina, United States
Skin Laser & Surgery Specialists of NY & NJ
🇺🇸
Hackensack, New Jersey, United States
Maryland Laser, Skin & Vein Institute
🇺🇸
Hunt Valley, Maryland, United States
Austin Institute for Clinical Research
🇺🇸
Pflugerville, Texas, United States