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

Sebacia, Inc.168 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

168

Conditions

Acne Vulgaris

Interventions

Sebacia MicroparticlesDEVICE

Topical microparticle suspension

Nd:Yag LaserDEVICE

Laser delivering 1064 nm wavelength light

Eligibility

Sex: ALLMin age: 12 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (11)

Clear Dermatology & Aesthetics Center

Scottsdale, Arizona, United States

Scripps Health

San Diego, California, United States

Miami Dermatology & Laser Institute

Miami, Florida, United States

Outcomes

Primary Outcomes

Change in number of inflammatory acne lesions

Time frame: Week 12

Data from ClinicalTrials.gov

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