Sebacia Postmarket Study of Real-World Use

October 24, 2020 updated by: Sebacia, Inc.

A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33173
        • Miami Dermatology & Laser Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Dermatology Institute of Boston
    • Tennessee
      • Murfreesboro, Tennessee, United States, 37130
        • International Clinical Research
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Institute for Clinical Research - Central
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research - Pflugerville
    • Washington
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • Sebacia treatment, Microparticles and Nd:Yag laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Lesion Count
Time Frame: Months 2, 3, 6, 9 and 12
Percent change in number of inflammatory lesions from baseline
Months 2, 3, 6, 9 and 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sebacia, Inc.

Investigators

  • Study Director: VP, Clinical & Regulatory Affairs, Sebacia, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (ACTUAL)

January 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 27, 2020

Last Update Submitted That Met QC Criteria

October 24, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEB-0550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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