Sebacia Postmarket Study of Real-World Use

NCT ID: NCT03818555

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sebacia Microparticles Treatment

Group Type OTHER

Sebacia Microparticles Treatment

Intervention Type OTHER

Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.

Interventions

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Sebacia Microparticles Treatment

Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.

Intervention Type OTHER

Other Intervention Names

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Sebacia treatment, Microparticles and Nd:Yag laser treatment

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sebacia, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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VP, Clinical & Regulatory Affairs

Role: STUDY_DIRECTOR

Sebacia, Inc.

Locations

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Miami Dermatology & Laser Institute

Miami, Florida, United States

Site Status

Dermatology Institute of Boston

Boston, Massachusetts, United States

Site Status

International Clinical Research

Murfreesboro, Tennessee, United States

Site Status

Austin Institute for Clinical Research - Central

Austin, Texas, United States

Site Status

Austin Institute for Clinical Research - Pflugerville

Pflugerville, Texas, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Countries

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United States

Related Links

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http://www.sebacia.com

Company Website

Other Identifiers

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SEB-0550

Identifier Type: -

Identifier Source: org_study_id