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Trial record 4 of 81 for:    acne | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Sebacia, Inc.
Sponsor:
Information provided by (Responsible Party):
Sebacia, Inc.
ClinicalTrials.gov Identifier:
NCT02758041
First received: April 19, 2016
Last updated: June 15, 2016
Last verified: April 2016
  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: 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 ]

Estimated Enrollment: 60
Study Start Date: February 2016
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sebacia Microparticles Device: Sebacia Microparticles

  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02758041

Contacts
Contact: Cory Anderson 678-417-7626

Locations
Denmark
Lasercenter North Recruiting
Aalborg, Denmark, 9220
Contact: Mariann Wittendorff    +45 98 12 52 59      
Principal Investigator: Hans Lomholt, M.D., Ph.D.         
Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen Completed
Copenhagen, Denmark, 2400
Switzerland
SKINPULSE Dermatology Laser & Beauty Center Recruiting
Geneva, Switzerland, 1205
Contact: Silvia Ferrari    4122 807 2777    silvia@skinpulse.ch   
Principal Investigator: Maurice Adatto, MD         
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
Study First Received: April 19, 2016
Last Updated: June 15, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Sebacia, Inc.:
Acne

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

ClinicalTrials.gov processed this record on March 23, 2017