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

October 2, 2019 updated by: Sebacia, Inc.

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

Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

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

8 years to 41 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in number of inflammatory acne lesions
Time Frame: Week 12
Week 12

Collaborators and Investigators

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

Sponsor

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)

September 25, 2017

Primary Completion (Actual)

April 10, 2018

Study Completion (Actual)

April 10, 2018

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 2, 2017

First Posted (Actual)

October 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 14, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEB-0493

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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