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

Not Applicable
Completed
Conditions
Acne Vulgaris
Interventions
Device: Sebacia Microparticles
Registration Number
NCT03303170
Lead Sponsor
Sebacia, Inc.
Brief Summary

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

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
168
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sebacia MicroparticlesSebacia Microparticles-
Primary Outcome Measures
NameTimeMethod
Change in number of inflammatory acne lesionsWeek 12
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

MediSearch Clinical Trials

🇺🇸

Saint Joseph, Missouri, United States

Meridian Clinical Research

🇺🇸

Savannah, Georgia, United States

Miami Dermatology & Laser Institute

🇺🇸

Miami, Florida, United States

Austin Institute for Clinical Research

🇺🇸

Austin, Texas, United States

International Clinical Research

🇺🇸

Murfreesboro, Tennessee, United States

Scripps Health

🇺🇸

San Diego, California, United States

Clear Dermatology & Aesthetics Center

🇺🇸

Scottsdale, Arizona, United States

Wake Research Associates

🇺🇸

Raleigh, North Carolina, United States

Dermatology, Laser & Vein Institute

🇺🇸

Charlotte, North Carolina, United States

The Center for Skin Research

🇺🇸

Katy, Texas, United States

Premier Clinical Research

🇺🇸

Spokane, Washington, United States

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