Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

September 5, 2017 updated by: Sebacia, Inc.

A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris

Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of acne vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

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

  • Poland
      • Krakow, Poland, 31-530
        • Specjalistyczny Gabinet Dermatologiczny
      • Warsaw, Poland, 04-141
        • Military Institute of Health Services

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

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of moderate to severe acne vulgaris

Exclusion Criteria:

  • use of oral retinoid therapy in the past 12 months
  • pregnancy, lactating, or planning to become pregnant
  • excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne

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 microparticle and laser treatment
Device: Sebacia microparticle and laser treatment
Sham Comparator: Vehicle and laser treatment
Device: Vehicle and laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in inflammatory lesion count
Time Frame: Week 12
Week 12
Number of adverse events
Time Frame: Screening to 26 weeks
Screening to 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigator Global Assessment
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.

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)

June 1, 2011

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEB-0005

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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