Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris
1 other identifier
interventional
168
1 country
11
Brief Summary
Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
11 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
September 25, 2017
CompletedFirst Submitted
Initial submission to the registry
October 2, 2017
CompletedFirst Posted
Study publicly available on registry
October 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2018
CompletedOctober 14, 2019
October 1, 2019
7 months
October 2, 2017
October 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in number of inflammatory acne lesions
Week 12
Study Arms (2)
Sebacia Microparticles
EXPERIMENTALNd:Yag Laser
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Mild to moderate acne vulgaris
- At least 15 inflammatory acne lesions
- Skin phototype I - III
- Able to understand and comply with study requirements
You may not qualify if:
- Severe acne vulgaris
- Nodulocystic acne
- Ongoing use of medications and/or treatments for acne
- New hormone regimen (used for less than 12 weeks)
- Significant medical or mental health condition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sebacia, Inc.lead
Study Sites (11)
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, 85255, United States
Scripps Health
San Diego, California, 92121, United States
Miami Dermatology & Laser Institute
Miami, Florida, 33173, United States
Meridian Clinical Research
Savannah, Georgia, 31406, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506, United States
Dermatology, Laser & Vein Institute
Charlotte, North Carolina, 28207, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
International Clinical Research
Murfreesboro, Tennessee, 37130, United States
Austin Institute for Clinical Research
Austin, Texas, 78660, United States
The Center for Skin Research
Katy, Texas, 77494, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2017
First Posted
October 5, 2017
Study Start
September 25, 2017
Primary Completion
April 10, 2018
Study Completion
April 10, 2018
Last Updated
October 14, 2019
Record last verified: 2019-10