Status:
COMPLETED
Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
Lead Sponsor:
Sebacia, Inc.
Conditions:
Inflammatory Acne Vulgaris
Eligibility:
All Genders
15-35 years
Phase:
NA
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 vu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT02217228
Start Date
September 1 2014
End Date
December 1 2015
Last Update
September 18 2017
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, United States, 85255
2
Laser & Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
3
Center for Dermatology & Laser Surgery
Sacramento, California, United States, 95819
4
Miami Dermatology & Laser Institute
Miami, Florida, United States, 33173