A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris

September 5, 2017 updated by: Sebacia, Inc.
This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

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

  • Denmark
      • Aalborg, Denmark, 9220
        • Lasercenter North
      • Copenhagen, Denmark, 2400
        • Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
  • Switzerland
      • Geneva, Switzerland, 1205
        • SKINPULSE Dermatology Laser & Beauty Center

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 41 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, 16-45 years of age.
  2. Moderate to moderately-severe facial inflammatory acne vulgaris
  3. Fitzpatrick skin phototype I-III

Exclusion Criteria:

  1. Pregnant, lactating, nursing or planning to become pregnant
  2. Tattoo in the treatment area
  3. Active skin disease, excessive scarring or excess facial hair in the treatment area
  4. Certain current or recent acne treatments
  5. Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
  6. Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
  7. Known allergy to gold

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sebacia Microparticles
Device: Sebacia Microparticles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent reduction in lesion count from baseline
Time Frame: Baseline, Week 12, Week 24, Week 36
Baseline, Week 12, Week 24, Week 36

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in Investigator Global Acne Score
Time Frame: Baseline, Week 12, Week 24, Week 36
Baseline, Week 12, Week 24, Week 36

Collaborators and Investigators

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

Sponsor

Sebacia, Inc.

Investigators

  • Principal Investigator: Merete Haedersdal, MD, PhD, Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen

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)

February 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

May 2, 2016

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEB-0294CH, SEB-0400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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