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Sebacia Postmarket Study of Real-World Use

Sponsor
Sebacia, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03818555
Collaborator
(none)
125
Enrollment
6
Locations
1
Arm
29
Anticipated Duration (Months)
20.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for patients with mild to moderate inflammatory acne vulgaris.

Condition or Disease Intervention/Treatment Phase
  • Other: Sebacia Microparticles Treatment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate Inflammatory Acne Vulgaris
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Sebacia Microparticles Treatment

Other: Sebacia Microparticles Treatment
Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.
Other Names:
  • Sebacia treatment, Microparticles and Nd:Yag laser treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Inflammatory Lesion Count [Months 2, 3, 6, 9 and 12]

      Percent change in number of inflammatory lesions from baseline

    Secondary Outcome Measures

    1. Investigator's Global Assessment [Months 2, 3, 6, 9 and 12]

      Percent of subjects clear (IGA 0) or almost clear (IGA 1)

    2. Physician's Overall Assessment of Improvement [Months 2, 3, 6, 9 and 12]

      Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3)

    • Between 10 and 50 papules/pustules

    • Fitzpatrick skin phototype I, II or III

    • Able to provide informed consent and comply with study schedule and other requirements

    Exclusion Criteria:

    • Moderately severe or severe acne vulgaris (IGA 4 or 5)

    • Nodulocystic acne, significant scarring or excoriation

    • Requires oral retinoid, antibiotic or corticosteroid for acne

    • New or fluctuating hormone or hormone-regulating therapy

    • Photosensitivity or allergy to gold

    • Medical or mental health condition that would pose a risk to patient or impair treatment and evaluation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Miami Dermatology & Laser Institute Miami Florida United States 33173
    2 Dermatology Institute of Boston Boston Massachusetts United States 02116
    3 International Clinical Research Murfreesboro Tennessee United States 37130
    4 Austin Institute for Clinical Research - Central Austin Texas United States 78705
    5 Austin Institute for Clinical Research - Pflugerville Pflugerville Texas United States 78660
    6 Premier Clinical Research Spokane Washington United States 99202

    Sponsors and Collaborators

    • Sebacia, Inc.

    Investigators

    • Study Director: VP, Clinical & Regulatory Affairs, Sebacia, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sebacia, Inc.
    ClinicalTrials.gov Identifier:
    NCT03818555
    Other Study ID Numbers:
    • SEB-0550
    First Posted:
    Jan 28, 2019
    Last Update Posted:
    Oct 27, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Acne Vulgaris

    Study Results

    No Results Posted as of Oct 27, 2020