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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
394

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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