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

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ClinicalTrials.gov Identifier: NCT02219074
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : September 7, 2017
Sponsor:
Information provided by (Responsible Party):
Sebacia, Inc.

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: Sebacia microparticle and laser treatment Device: Vehicle and laser treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris
Actual Study Start Date : June 2011
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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



Primary Outcome Measures :
  1. Change in inflammatory lesion count [ Time Frame: Week 12 ]
  2. Number of adverse events [ Time Frame: Screening to 26 weeks ]

Secondary Outcome Measures :
  1. Investigator Global Assessment [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02219074


Locations
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Poland
Specjalistyczny Gabinet Dermatologiczny
Krakow, Poland, 31-530
Military Institute of Health Services
Warsaw, Poland, 04-141
Sponsors and Collaborators
Sebacia, Inc.

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Responsible Party: Sebacia, Inc.
ClinicalTrials.gov Identifier: NCT02219074     History of Changes
Other Study ID Numbers: SEB-0005
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases