Back to resultsMultiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Sebacia microparticle and laser treatment
Vehicle and laser treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of moderate to severe acne vulgaris
Exclusion Criteria:
- 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
Sites / Locations
- Specjalistyczny Gabinet Dermatologiczny
- Military Institute of Health Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Sebacia microparticle and laser treatment
Vehicle and laser treatment
Arm Description
Outcomes
Primary Outcome Measures
Change in inflammatory lesion count
Number of adverse events
Secondary Outcome Measures
Investigator Global Assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02219074
Brief Title
Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
Official Title
A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (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, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of 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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sebacia microparticle and laser treatment
Arm Type
Experimental
Arm Title
Vehicle and laser treatment
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Sebacia microparticle and laser treatment
Intervention Type
Device
Intervention Name(s)
Vehicle and laser treatment
Primary Outcome Measure Information:
Title
Change in inflammatory lesion count
Time Frame
Week 12
Title
Number of adverse events
Time Frame
Screening to 26 weeks
Secondary Outcome Measure Information:
Title
Investigator Global Assessment
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of moderate to severe acne vulgaris
Exclusion Criteria:
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
Facility Information:
Facility Name
Specjalistyczny Gabinet Dermatologiczny
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
Facility Name
Military Institute of Health Services
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
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