search
Back to results

Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Primary Purpose

Inflammatory Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sebacia microparticles and laser
Vehicle suspension and laser
Sebacia microparticles without laser
Sponsored by
Sebacia, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Acne Vulgaris

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Clear Dermatology & Aesthetics Center
  • Laser & Skin Surgery Center of Northern California
  • Center for Dermatology & Laser Surgery
  • Miami Dermatology & Laser Institute
  • Spencer Dermatology
  • Gwinnett Dermatology, PC
  • The Dermatology Institute-DuPage Medical Group
  • Shideler Clinical Research Center
  • Maryland Laser, Skin & Vein Institute
  • Clarkston Skin Research
  • James Q Del Rosso, DO, LLC
  • Skin Laser & Surgery Specialists of NY & NJ
  • Dermatology, Laser & Vein Specialists of the Carolinas
  • Penn State Hershey Medical Center
  • Yardley Dermatology Associates
  • Dermatology & Laser Center of Charleston
  • Tennessee Clinical Research Center
  • Austin Institute for Clinical Research
  • Spokane Dermatology Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sebacia microparticles and laser

Vehicle suspension and laser

Sebacia microparticles without laser

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Mean percent change in inflammatory lesion count from Baseline to Week 12
Number of of adverse events

Secondary Outcome Measures

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

Full Information

First Posted
August 11, 2014
Last Updated
September 8, 2017
Sponsor
Sebacia, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02217228
Brief Title
Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sebacia, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sebacia microparticles and laser
Arm Type
Experimental
Arm Description
Gold microparticle suspension + laser treatment x 3 over the course of two weeks
Arm Title
Vehicle suspension and laser
Arm Type
Experimental
Arm Description
Vehicle suspension + laser treatment x 3 over the course of two weeks
Arm Title
Sebacia microparticles without laser
Arm Type
Experimental
Arm Description
Gold microparticle suspension treatment x 3 over the course of two weeks
Intervention Type
Device
Intervention Name(s)
Sebacia microparticles and laser
Intervention Type
Device
Intervention Name(s)
Vehicle suspension and laser
Intervention Type
Device
Intervention Name(s)
Sebacia microparticles without laser
Primary Outcome Measure Information:
Title
Mean percent change in inflammatory lesion count from Baseline to Week 12
Time Frame
Week 12
Title
Number of of adverse events
Time Frame
Screening to 12 Weeks
Secondary Outcome Measure Information:
Title
Mean absolute change in inflammatory lesion count from Baseline to Week 12
Time Frame
Week 12
Title
Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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
Facility Information:
Facility Name
Clear Dermatology & Aesthetics Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Laser & Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Center for Dermatology & Laser Surgery
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Miami Dermatology & Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Spencer Dermatology
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Gwinnett Dermatology, PC
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
The Dermatology Institute-DuPage Medical Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Shideler Clinical Research Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Maryland Laser, Skin & Vein Institute
City
Hunt Valley
State/Province
Maryland
ZIP/Postal Code
21030
Country
United States
Facility Name
Clarkston Skin Research
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Facility Name
James Q Del Rosso, DO, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Skin Laser & Surgery Specialists of NY & NJ
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Dermatology, Laser & Vein Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Yardley Dermatology Associates
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Dermatology & Laser Center of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Spokane Dermatology Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
92204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

We'll reach out to this number within 24 hrs