Inflammatory Acne Vulgaris
Conditions
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
Interventions
DEVICESebacia microparticles and laser
DEVICEVehicle suspension and laser
DEVICESebacia microparticles without laser
Sponsors
Sebacia, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 35 Years
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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change in inflammatory lesion count from Baseline to Week 12 | Week 12 |
| Number of of adverse events | Screening to 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed