Sebacia Postmarket Study of Real-World Use
A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris
1 other identifier
interventional
125
1 country
6
Brief Summary
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 24, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedOctober 27, 2020
October 1, 2020
2.4 years
January 24, 2019
October 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Inflammatory Lesion Count
Percent change in number of inflammatory lesions from baseline
Months 2, 3, 6, 9 and 12
Secondary Outcomes (2)
Investigator's Global Assessment
Months 2, 3, 6, 9 and 12
Physician's Overall Assessment of Improvement
Months 2, 3, 6, 9 and 12
Study Arms (1)
Sebacia Microparticles Treatment
OTHERInterventions
Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sebacia, Inc.lead
Study Sites (6)
Miami Dermatology & Laser Institute
Miami, Florida, 33173, United States
Dermatology Institute of Boston
Boston, Massachusetts, 02116, United States
International Clinical Research
Murfreesboro, Tennessee, 37130, United States
Austin Institute for Clinical Research - Central
Austin, Texas, 78705, United States
Austin Institute for Clinical Research - Pflugerville
Pflugerville, Texas, 78660, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
VP, Clinical & Regulatory Affairs
Sebacia, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2019
First Posted
January 28, 2019
Study Start
January 1, 2019
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
October 27, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share