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Completed

NCT Number: NCT02219074

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

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

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Specjalistyczny Gabinet Dermatologiczny, Krakow, Poland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sebacia microparticle and laser treatment

Device

Vehicle and laser treatment

Device

Primary outcomes

  1. Change in inflammatory lesion count

    Time frame: Week 12

  2. Number of adverse events

    Time frame: Screening to 26 weeks

Secondary outcomes

  1. Investigator Global Assessment

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Sebacia, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2014
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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