Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Sebacia

Status: Completed

Conditions: Inflammatory Acne Vulgaris

Treatments: Device: Sebacia microparticles and laser; Device: Sebacia microparticles without laser; Device: Vehicle suspension and laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT02217228

IDE #G120273 (Other Identifier)

SEB-0121

Details and patient eligibility

About

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

Enrollment: 394 patients

Sex: All

Ages: 15 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

394 participants in 3 patient groups

Sebacia microparticles and laser

Experimental group

Description:

Gold microparticle suspension + laser treatment x 3 over the course of two weeks

Treatment:

Device: Sebacia microparticles and laser

Vehicle suspension and laser

Experimental group

Description:

Vehicle suspension + laser treatment x 3 over the course of two weeks

Treatment:

Device: Vehicle suspension and laser

Sebacia microparticles without laser

Experimental group

Description:

Gold microparticle suspension treatment x 3 over the course of two weeks

Treatment:

Device: Sebacia microparticles without laser