Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Not Applicable

Completed

• Conditions: Inflammatory Acne Vulgaris

• Registration Number: NCT02217228
• Lead Sponsor: Sebacia, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-14
• Study First Posted: 2014-08-15
• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-09
• Disposition First Submitted: 2017-09-05
• Disposition First Submitted QC: 2017-09-08
• Last Update Submitted: 2017-09-08
• Disposition First Posted: 2017-09-18
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 394

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean percent change in inflammatory lesion count from Baseline to Week 12	Week 12
Number of of adverse events	Screening to 12 Weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Clear Dermatology & Aesthetics Center; 🇺🇸 Scottsdale, Arizona, United States

Laser & Skin Surgery Center of Northern California; 🇺🇸 Sacramento, California, United States

Center for Dermatology & Laser Surgery; 🇺🇸 Sacramento, California, United States

Miami Dermatology & Laser Institute; 🇺🇸 Miami, Florida, United States

Spencer Dermatology; 🇺🇸 Saint Petersburg, Florida, United States

Gwinnett Dermatology, PC; 🇺🇸 Snellville, Georgia, United States

The Dermatology Institute-DuPage Medical Group; 🇺🇸 Naperville, Illinois, United States

Shideler Clinical Research Center; 🇺🇸 Carmel, Indiana, United States

Maryland Laser, Skin & Vein Institute; 🇺🇸 Hunt Valley, Maryland, United States

Clarkston Skin Research; 🇺🇸 Clarkston, Michigan, United States

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