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

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

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