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

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ClinicalTrials.gov Identifier: NCT03303170
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Sebacia, Inc.

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: Sebacia Microparticles Device: Nd:Yag Laser Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : April 10, 2018
Actual Study Completion Date : April 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Sebacia Microparticles Device: Sebacia Microparticles
Topical microparticle suspension

Active Comparator: Nd:Yag Laser Device: Nd:Yag Laser
Laser delivering 1064 nm wavelength light




Primary Outcome Measures :
  1. Change in number of inflammatory acne lesions [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303170


Locations
United States, Arizona
Clear Dermatology & Aesthetics Center
Scottsdale, Arizona, United States, 85255
United States, California
Scripps Health
San Diego, California, United States, 92121
United States, Florida
Miami Dermatology & Laser Institute
Miami, Florida, United States, 33173
United States, Georgia
Meridian Clinical Research
Savannah, Georgia, United States, 31406
United States, Missouri
MediSearch Clinical Trials
Saint Joseph, Missouri, United States, 64506
United States, North Carolina
Dermatology, Laser & Vein Institute
Charlotte, North Carolina, United States, 28207
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Tennessee
International Clinical Research
Murfreesboro, Tennessee, United States, 37130
United States, Texas
Austin Institute for Clinical Research
Austin, Texas, United States, 78660
The Center for Skin Research
Katy, Texas, United States, 77494
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Sebacia, Inc.

Additional Information:
Responsible Party: Sebacia, Inc.
ClinicalTrials.gov Identifier: NCT03303170     History of Changes
Other Study ID Numbers: SEB-0493
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases