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

Not Applicable

Completed

• Conditions: Acne Vulgaris
• Interventions: Device: Sebacia microparticle and laser treatment; Device: Vehicle and laser treatment

• Registration Number: NCT02219074
• Lead Sponsor: Sebacia, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-18
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sebacia microparticle and laser treatment	Sebacia microparticle and laser treatment	-
Vehicle and laser treatment	Vehicle and laser treatment	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	Screening to 26 weeks
Change in inflammatory lesion count	Week 12

Secondary Outcome Measures

Name	Time	Method
Investigator Global Assessment	Week 12

Trial Locations

Locations (2)

Specjalistyczny Gabinet Dermatologiczny; 🇵🇱 Krakow, Poland

Military Institute of Health Services; 🇵🇱 Warsaw, Poland