Back to resultsSebacia Postmarket Study of Real-World Use
Primary Purpose
Acne Vulgaris
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sebacia Microparticles Treatment
Sponsored by
About this trial
This is an interventional other trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3)
- Between 10 and 50 papules/pustules
- Fitzpatrick skin phototype I, II or III
- Able to provide informed consent and comply with study schedule and other requirements
Exclusion Criteria:
- Moderately severe or severe acne vulgaris (IGA 4 or 5)
- Nodulocystic acne, significant scarring or excoriation
- Requires oral retinoid, antibiotic or corticosteroid for acne
- New or fluctuating hormone or hormone-regulating therapy
- Photosensitivity or allergy to gold
- Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation
Sites / Locations
- Miami Dermatology & Laser Institute
- Dermatology Institute of Boston
- International Clinical Research
- Austin Institute for Clinical Research - Central
- Austin Institute for Clinical Research - Pflugerville
- Premier Clinical Research
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Sebacia Microparticles Treatment
Arm Description
Outcomes
Primary Outcome Measures
Inflammatory Lesion Count
Percent change in number of inflammatory lesions from baseline
Secondary Outcome Measures
Investigator's Global Assessment
Percent of subjects clear (IGA 0) or almost clear (IGA 1)
Physician's Overall Assessment of Improvement
Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03818555
Brief Title
Sebacia Postmarket Study of Real-World Use
Official Title
A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sebacia, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sebacia Microparticles Treatment
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Sebacia Microparticles Treatment
Other Intervention Name(s)
Sebacia treatment, Microparticles and Nd:Yag laser treatment
Intervention Description
Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.
Primary Outcome Measure Information:
Title
Inflammatory Lesion Count
Description
Percent change in number of inflammatory lesions from baseline
Time Frame
Months 2, 3, 6, 9 and 12
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment
Description
Percent of subjects clear (IGA 0) or almost clear (IGA 1)
Time Frame
Months 2, 3, 6, 9 and 12
Title
Physician's Overall Assessment of Improvement
Description
Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete)
Time Frame
Months 2, 3, 6, 9 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3)
Between 10 and 50 papules/pustules
Fitzpatrick skin phototype I, II or III
Able to provide informed consent and comply with study schedule and other requirements
Exclusion Criteria:
Moderately severe or severe acne vulgaris (IGA 4 or 5)
Nodulocystic acne, significant scarring or excoriation
Requires oral retinoid, antibiotic or corticosteroid for acne
New or fluctuating hormone or hormone-regulating therapy
Photosensitivity or allergy to gold
Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VP, Clinical & Regulatory Affairs
Organizational Affiliation
Sebacia, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Miami Dermatology & Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Dermatology Institute of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Facility Name
International Clinical Research
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Austin Institute for Clinical Research - Central
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Austin Institute for Clinical Research - Pflugerville
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.sebacia.com
Description
Company Website
URL
http://www.acneclinicalstudy.com
Description
Study Website
Learn more about this trial
Sebacia Postmarket Study of Real-World Use
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