Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

September 8, 2017 updated by: Sebacia, Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Clear Dermatology & Aesthetics Center
    • California
      • Sacramento, California, United States, 95816
        • Laser & Skin Surgery Center of Northern California
      • Sacramento, California, United States, 95819
        • Center for Dermatology & Laser Surgery
    • Florida
      • Miami, Florida, United States, 33173
        • Miami Dermatology & Laser Institute
      • Saint Petersburg, Florida, United States, 33716
        • Spencer Dermatology
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Gwinnett Dermatology, PC
    • Illinois
      • Naperville, Illinois, United States, 60563
        • The Dermatology Institute-DuPage Medical Group
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Shideler Clinical Research Center
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Maryland Laser, Skin & Vein Institute
    • Michigan
      • Clarkston, Michigan, United States, 48346
        • Clarkston Skin Research
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • James Q Del Rosso, DO, LLC
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Skin Laser & Surgery Specialists of NY & NJ
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Dermatology, Laser & Vein Specialists of the Carolinas
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Yardley, Pennsylvania, United States, 19067
        • Yardley Dermatology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Dermatology & Laser Center of Charleston
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research
    • Washington
      • Spokane, Washington, United States, 92204
        • Spokane Dermatology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 31 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sebacia microparticles and laser
Gold microparticle suspension + laser treatment x 3 over the course of two weeks
Device: Sebacia microparticles and laser
Experimental: Vehicle suspension and laser
Vehicle suspension + laser treatment x 3 over the course of two weeks
Device: Vehicle suspension and laser
Experimental: Sebacia microparticles without laser
Gold microparticle suspension treatment x 3 over the course of two weeks
Device: Sebacia microparticles without laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean percent change in inflammatory lesion count from Baseline to Week 12
Time Frame: Week 12
Week 12
Number of of adverse events
Time Frame: Screening to 12 Weeks
Screening to 12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean absolute change in inflammatory lesion count from Baseline to Week 12
Time Frame: Week 12
Week 12
Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sebacia, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEB-0121
  • IDE #G120273 (Other Identifier: FDA CDRH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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