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NCT02219074 Clinical Trial

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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02219074
Other study ID # SEB-0005
Secondary ID
Status Completed
Phase N/A
First received August 14, 2014
Last updated September 5, 2017
Start date June 2011
Est. completion date October 2016

Study information
Verified date September 2017
Source Sebacia, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 16 Years to 35 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Sebacia microparticle and laser treatment

• Vehicle and laser treatment

Locations
Country Name City State
Poland Specjalistyczny Gabinet Dermatologiczny Krakow
Poland Military Institute of Health Services Warsaw

Sponsors (1)
Lead Sponsor Collaborator
Sebacia, Inc.

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in inflammatory lesion count Week 12
Primary Number of adverse events Screening to 26 weeks
Secondary Investigator Global Assessment Week 12
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