Multiple Arm Study of Sebacia Microparticles in the Treat... | NCT02219074

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

NCT02219074

Sponsor

Sebacia, Inc.

Status

Completed

Last Update Posted

Sep 7, 2017Actual

Enrollment

350Actual

Phase

Not Applicable

Conditions

Acne Vulgaris

Interventions

Sebacia microparticle and laser treatment
Vehicle and laser treatment

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011Actual

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Aug 14, 2014

First Submission Date that Met QC Criteria

Aug 15, 2014

First Posted Date

Aug 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2017

Last Update Posted Date

Sep 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sebacia microparticle and laser treatment	Experimental		Device: Sebacia microparticle and laser treatment
Vehicle and laser treatment	Sham Comparator		Device: Vehicle and laser treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sebacia microparticle and laser treatment	Device		Sebacia microparticle and laser treatment
Vehicle and laser treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Investigator Global Assessment		Week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

35 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Specjalistyczny Gabinet Dermatologiczny		Krakow		31-530	Poland
Military Institute of Health Services

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided