Back to resultsA Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
Primary Purpose
Facial Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Sebacia Microparticles
Sponsored by
About this trial
This is an interventional treatment trial for Facial Acne Vulgaris focused on measuring Acne
Eligibility Criteria
Inclusion Criteria:
- Male or female, 16-45 years of age.
- Moderate to moderately-severe facial inflammatory acne vulgaris
- Fitzpatrick skin phototype I-III
Exclusion Criteria:
- Pregnant, lactating, nursing or planning to become pregnant
- Tattoo in the treatment area
- Active skin disease, excessive scarring or excess facial hair in the treatment area
- Certain current or recent acne treatments
- Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
- Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
- Known allergy to gold
Sites / Locations
- Lasercenter North
- Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
- SKINPULSE Dermatology Laser & Beauty Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sebacia Microparticles
Arm Description
Outcomes
Primary Outcome Measures
Percent reduction in lesion count from baseline
Secondary Outcome Measures
Improvement in Investigator Global Acne Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02758041
Brief Title
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
Official Title
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
February 2017 (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
This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Acne Vulgaris
Keywords
Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sebacia Microparticles
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sebacia Microparticles
Primary Outcome Measure Information:
Title
Percent reduction in lesion count from baseline
Time Frame
Baseline, Week 12, Week 24, Week 36
Secondary Outcome Measure Information:
Title
Improvement in Investigator Global Acne Score
Time Frame
Baseline, Week 12, Week 24, Week 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 16-45 years of age.
Moderate to moderately-severe facial inflammatory acne vulgaris
Fitzpatrick skin phototype I-III
Exclusion Criteria:
Pregnant, lactating, nursing or planning to become pregnant
Tattoo in the treatment area
Active skin disease, excessive scarring or excess facial hair in the treatment area
Certain current or recent acne treatments
Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
Known allergy to gold
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Haedersdal, MD, PhD
Organizational Affiliation
Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lasercenter North
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark
Facility Name
Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
SKINPULSE Dermatology Laser & Beauty Center
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris
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