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Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02217228
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Sebacia, Inc.

Study Description
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Brief Summary:
Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia microparticles with or without laser in the treatment of moderate to moderately-severe inflammatory acne vulgaris

Condition or disease Intervention/treatment Phase
Inflammatory Acne Vulgaris Device: Sebacia microparticles and laser Device: Vehicle suspension and laser Device: Sebacia microparticles without laser Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Multicenter, Controlled Study With Blinded Assessment to Determine the Safety and Effectiveness of the Sebacia Acne Treatment System in the Treatment of Inflammatory Acne Vulgaris
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sebacia microparticles and laser
Gold microparticle suspension + laser treatment x 3 over the course of two weeks
 Device: Sebacia microparticles and laser
Experimental: Vehicle suspension and laser
Vehicle suspension + laser treatment x 3 over the course of two weeks
 Device: Vehicle suspension and laser
Experimental: Sebacia microparticles without laser
Gold microparticle suspension treatment x 3 over the course of two weeks
 Device: Sebacia microparticles without laser


Outcome Measures
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Primary Outcome Measures :
  1. Mean percent change in inflammatory lesion count from Baseline to Week 12 [ Time Frame: Week 12 ]
  2. Number of of adverse events [ Time Frame: Screening to 12 Weeks ]

Secondary Outcome Measures :
  1. Mean absolute change in inflammatory lesion count from Baseline to Week 12 [ Time Frame: Week 12 ]
  2. Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA) [ Time Frame: Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 15 - 45 years of age
  • Able to provide informed consent/assent; minors will provide assent while parent or legal guardian will provide consent
  • Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's Global Assessment
  • Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not concentrated in one area
  • Subject has Fitzpatrick skin phototype I, II or III
  • Subject is in good health, willing to participate and able to comply with protocol requirements

Exclusion Criteria:

  • Severe acne (Investigator's Global Assessment 5) with significant scarring potential and greater than 2 nodular lesions
  • Clinically relevant history of keloids
  • Facial tattoos
  • Acne conglobata, acne fulminans, chloracne, drug-induced acne
  • Active concomitant skin disease, excessive scarring or excess facial hair
  • Heavily tanned skin; unable or unwilling to avoid tanning beds/excessive sun exposure

  • Acne medication and therapy restrictions - time period prior to Baseline (below)

    1. Oral retinoids - 6 months
    2. Other systemic medications - 4 weeks
    3. Topical retinoids, steroids, antibiotics - 2 weeks
    4. OTC topical treatments - 1 week
    5. Light treatments (including IPL or laser), microdermabrasion and/or peels - 8 weeks
    6. Investigational drug, biologic or device - 30 days
    7. Gold therapy of any type for any reason - EXCLUDED
  • Pregnant, lactating, nursing or planning to become pregnant during the study period
  • Known allergy to gold, ethanol, diisopropyl adipate, Polysorbate 80
  • Clinically relevant condition that makes participation unsafe or that would interfere with study treatment and assessment
Contacts and Locations
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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): NCT02217228


Locations
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Sponsors and Collaborators
Sebacia, Inc.
More Information
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Responsible Party: Sebacia, Inc.
ClinicalTrials.gov Identifier: NCT02217228    
Other Study ID Numbers: SEB-0121
IDE #G120273 ( Other Identifier: FDA CDRH )
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases