Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris
1 other identifier
interventional
350
1 country
2
Brief Summary
Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of 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 Jun 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 14, 2014
CompletedFirst Posted
Study publicly available on registry
August 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedSeptember 7, 2017
September 1, 2017
5.3 years
August 14, 2014
September 5, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Change in inflammatory lesion count
Week 12
Number of adverse events
Screening to 26 weeks
Secondary Outcomes (1)
Investigator Global Assessment
Week 12
Study Arms (2)
Sebacia microparticle and laser treatment
EXPERIMENTALVehicle and laser treatment
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of moderate to severe acne vulgaris
You may not qualify if:
- use of oral retinoid therapy in the past 12 months
- pregnancy, lactating, or planning to become pregnant
- excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sebacia, Inc.lead
Study Sites (2)
Specjalistyczny Gabinet Dermatologiczny
Krakow, 31-530, Poland
Military Institute of Health Services
Warsaw, 04-141, Poland
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
August 14, 2014
First Posted
August 18, 2014
Study Start
June 1, 2011
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
September 7, 2017
Record last verified: 2017-09