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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02758041
First Posted: May 2, 2016
Last Update Posted: September 7, 2017
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.
Information provided by (Responsible Party):
Sebacia, Inc.
  Purpose
This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory acne vulgaris.

Condition Intervention
Facial Acne Vulgaris Device: Sebacia Microparticles

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris

Resource links provided by NLM:


Further study details as provided by Sebacia, Inc.:

Primary Outcome Measures:
  • Percent reduction in lesion count from baseline [ Time Frame: Baseline, Week 12, Week 24, Week 36 ]

Secondary Outcome Measures:
  • Improvement in Investigator Global Acne Score [ Time Frame: Baseline, Week 12, Week 24, Week 36 ]

Enrollment: 85
Actual Study Start Date: February 2016
Study Completion Date: February 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sebacia Microparticles Device: Sebacia Microparticles

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT02758041


Locations
Denmark
Lasercenter North
Aalborg, Denmark, 9220
Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
Copenhagen, Denmark, 2400
Switzerland
SKINPULSE Dermatology Laser & Beauty Center
Geneva, Switzerland, 1205
Sponsors and Collaborators
Sebacia, Inc.
Investigators
Principal Investigator: Merete Haedersdal, MD, PhD Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen
  More Information

Responsible Party: Sebacia, Inc.
ClinicalTrials.gov Identifier: NCT02758041     History of Changes
Other Study ID Numbers: SEB-0294CH, SEB-0400
First Submitted: April 19, 2016
First Posted: May 2, 2016
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sebacia, Inc.:
Acne

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