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Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sebacia Microparticles
Nd:Yag Laser
Sponsored by
Sebacia, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild to moderate acne vulgaris
  • At least 15 inflammatory acne lesions
  • Skin phototype I - III
  • Able to understand and comply with study requirements

Exclusion Criteria:

  • 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

Sites / Locations

  • Clear Dermatology & Aesthetics Center
  • Scripps Health
  • Miami Dermatology & Laser Institute
  • Meridian Clinical Research
  • MediSearch Clinical Trials
  • Dermatology, Laser & Vein Institute
  • Wake Research Associates
  • International Clinical Research
  • Austin Institute for Clinical Research
  • The Center for Skin Research
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sebacia Microparticles

Nd:Yag Laser

Arm Description

Outcomes

Primary Outcome Measures

Change in number of inflammatory acne lesions

Secondary Outcome Measures

Full Information

First Posted
October 2, 2017
Last Updated
October 2, 2019
Sponsor
Sebacia, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03303170
Brief Title
Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
April 10, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sebacia, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

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
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sebacia Microparticles
Arm Type
Experimental
Arm Title
Nd:Yag Laser
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Sebacia Microparticles
Intervention Description
Topical microparticle suspension
Intervention Type
Device
Intervention Name(s)
Nd:Yag Laser
Intervention Description
Laser delivering 1064 nm wavelength light
Primary Outcome Measure Information:
Title
Change in number of inflammatory acne lesions
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild to moderate acne vulgaris At least 15 inflammatory acne lesions Skin phototype I - III Able to understand and comply with study requirements Exclusion Criteria: 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
Facility Information:
Facility Name
Clear Dermatology & Aesthetics Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Scripps Health
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Miami Dermatology & Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Dermatology, Laser & Vein Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
International Clinical Research
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
Austin Institute for Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
The Center for Skin Research
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sebacia.com
Description
Sponsor Website

Learn more about this trial

Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris

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