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

A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02219074

Enrollment

350

Registered

2014-08-18

Start date

2011-06-30

Completion date

2016-10-31

Last updated

2017-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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.

Interventions

DEVICESebacia microparticle and laser treatment

DEVICEVehicle and laser treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Investigator Global Assessment	Week 12

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026