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Sebacia Postmarket Study of Real-World Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03818555
Recruitment Status : Active, not recruiting
First Posted : January 28, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sebacia, Inc.

Brief Summary:
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Other: Sebacia Microparticles Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Sebacia Microparticles Treatment Other: Sebacia Microparticles Treatment
Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.
Other Name: Sebacia treatment, Microparticles and Nd:Yag laser treatment




Primary Outcome Measures :
  1. Inflammatory Lesion Count [ Time Frame: Months 2, 3, 6, 9 and 12 ]
    Percent change in number of inflammatory lesions from baseline


Secondary Outcome Measures :
  1. Investigator's Global Assessment [ Time Frame: Months 2, 3, 6, 9 and 12 ]
    Percent of subjects clear (IGA 0) or almost clear (IGA 1)

  2. Physician's Overall Assessment of Improvement [ Time Frame: Months 2, 3, 6, 9 and 12 ]
    Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete)



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 facial inflammatory acne vulgaris (IGA 2 or 3)
  • Between 10 and 50 papules/pustules
  • Fitzpatrick skin phototype I, II or III
  • Able to provide informed consent and comply with study schedule and other requirements

Exclusion Criteria:

  • Moderately severe or severe acne vulgaris (IGA 4 or 5)
  • Nodulocystic acne, significant scarring or excoriation
  • Requires oral retinoid, antibiotic or corticosteroid for acne
  • New or fluctuating hormone or hormone-regulating therapy
  • Photosensitivity or allergy to gold
  • Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation

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): NCT03818555


Locations
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United States, Florida
Miami Dermatology & Laser Institute
Miami, Florida, United States, 33173
United States, Massachusetts
Dermatology Institute of Boston
Boston, Massachusetts, United States, 02116
United States, Tennessee
International Clinical Research
Murfreesboro, Tennessee, United States, 37130
United States, Texas
Austin Institute for Clinical Research - Central
Austin, Texas, United States, 78705
Austin Institute for Clinical Research - Pflugerville
Pflugerville, Texas, United States, 78660
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Sebacia, Inc.
Investigators
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Study Director: VP, Clinical & Regulatory Affairs Sebacia, Inc.

Additional Information:
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Responsible Party: Sebacia, Inc.
ClinicalTrials.gov Identifier: NCT03818555     History of Changes
Other Study ID Numbers: SEB-0550
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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