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

NCT ID: NCT02219074

Last Updated: 2017-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-10-31

Brief Summary

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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

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sebacia microparticle and laser treatment

Group Type EXPERIMENTAL

Sebacia microparticle and laser treatment

Intervention Type DEVICE

Vehicle and laser treatment

Group Type SHAM_COMPARATOR

Vehicle and laser treatment

Intervention Type DEVICE

Interventions

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Sebacia microparticle and laser treatment

Intervention Type DEVICE

Vehicle and laser treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sebacia, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Specjalistyczny Gabinet Dermatologiczny

Krakow, , Poland

Site Status

Military Institute of Health Services

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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SEB-0005

Identifier Type: -

Identifier Source: org_study_id

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