Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

N/ACompletedNCT02219074

Sebacia, Inc.350 enrolled

Overview

Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of acne vulgaris.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

350

Conditions

Acne Vulgaris

Interventions

Sebacia microparticle and laser treatmentDEVICE

Vehicle and laser treatmentDEVICE

Eligibility

Sex: ALLMin age: 16 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * clinical diagnosis of moderate to severe acne vulgaris Exclusion Criteria: * use of oral retinoid therapy in the past 12 months * pregnancy, lactating, or planning to become pregnant * excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne

Locations (2)

Specjalistyczny Gabinet Dermatologiczny

Krakow, Poland

Military Institute of Health Services

Warsaw, Poland

Outcomes

Primary Outcomes

Change in inflammatory lesion count

Time frame: Week 12

Number of adverse events

Time frame: Screening to 26 weeks

Secondary Outcomes

Investigator Global Assessment

Time frame: Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.