NCT02217228CompletedNot Applicable
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
Sebacia, Inc.19 sites in 1 country394 target enrollmentStarted: September 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 394
- Locations
- 19
- Primary Endpoint
- Number of of adverse events
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 35 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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
Arms & Interventions
Sebacia microparticles and laser
Experimental
Gold microparticle suspension + laser treatment x 3 over the course of two weeks
Intervention: Sebacia microparticles and laser (Device)
Vehicle suspension and laser
Experimental
Vehicle suspension + laser treatment x 3 over the course of two weeks
Intervention: Vehicle suspension and laser (Device)
Sebacia microparticles without laser
Experimental
Gold microparticle suspension treatment x 3 over the course of two weeks
Intervention: Sebacia microparticles without laser (Device)
Outcomes
Primary Outcomes
Number of of adverse events
Time Frame: Screening to 12 Weeks
Mean percent change in inflammatory lesion count from Baseline to Week 12
Time Frame: Week 12
Secondary Outcomes
- 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)
Investigators
Study Sites (19)
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