Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris

NCT ID: NCT03303170

Last Updated: 2019-10-14

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

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2018-04-10

Brief Summary

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Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris

Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sebacia Microparticles

Group Type EXPERIMENTAL

Sebacia Microparticles

Intervention Type DEVICE

Topical microparticle suspension

Nd:Yag Laser

Group Type ACTIVE_COMPARATOR

Nd:Yag Laser

Intervention Type DEVICE

Laser delivering 1064 nm wavelength light

Interventions

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Sebacia Microparticles

Topical microparticle suspension

Intervention Type DEVICE

Nd:Yag Laser

Laser delivering 1064 nm wavelength light

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate acne vulgaris
* At least 15 inflammatory acne lesions
* Skin phototype I - III
* Able to understand and comply with study requirements

Exclusion Criteria

* Severe acne vulgaris
* Nodulocystic acne
* Ongoing use of medications and/or treatments for acne
* New hormone regimen (used for less than 12 weeks)
* Significant medical or mental health condition
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

Locations

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Clear Dermatology & Aesthetics Center

Scottsdale, Arizona, United States

Site Status

Scripps Health

San Diego, California, United States

Site Status

Miami Dermatology & Laser Institute

Miami, Florida, United States

Site Status

Meridian Clinical Research

Savannah, Georgia, United States

Site Status

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Site Status

Dermatology, Laser & Vein Institute

Charlotte, North Carolina, United States

Site Status

Wake Research Associates

Raleigh, North Carolina, United States

Site Status

International Clinical Research

Murfreesboro, Tennessee, United States

Site Status

Austin Institute for Clinical Research

Austin, Texas, United States

Site Status

The Center for Skin Research

Katy, 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

Sponsor Website

Other Identifiers

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SEB-0493

Identifier Type: -

Identifier Source: org_study_id

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