A Study to Evaluate Sebacia Microparticles in Patients Wi... | NCT02758041

Studies
A Study to Evaluate Sebacia Microparticles in Patients With Inflammatory Acne Vulgaris

NCT02758041

Sponsor

Sebacia, Inc.

Status

Completed

Last Update Posted

Sep 7, 2017Actual

Enrollment

85Actual

Phase

Not Applicable

Conditions

Facial Acne Vulgaris

Interventions

Sebacia Microparticles

Countries

Denmark
Switzerland

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

Feb 2016Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Apr 19, 2016

First Submission Date that Met QC Criteria

Apr 27, 2016

First Posted Date

May 2, 2016Estimated

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

This study is proposed to evaluate Sebacia Microparticle treatment in patients with facial inflammatory 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

85Actual

Label	Type	Description	Intervention Names
Sebacia Microparticles	Experimental		Device: Sebacia Microparticles

Name	Type	Description	Arm Group Labels	Other Names
Sebacia Microparticles	Device		Sebacia Microparticles

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent reduction in lesion count from baseline		Baseline, Week 12, Week 24, Week 36

Secondary Outcomes

Measure	Description	Time Frame
Improvement in Investigator Global Acne Score		Baseline, Week 12, Week 24, Week 36

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, 16-45 years of age.
Moderate to moderately-severe facial inflammatory acne vulgaris
Fitzpatrick skin phototype I-III

Exclusion Criteria:

Pregnant, lactating, nursing or planning to become pregnant
Tattoo in the treatment area
Active skin disease, excessive scarring or excess facial hair in the treatment area
Certain current or recent acne treatments
Recent light treatments including Intense Pulsed Light or other lasers, microdermabrasion or chemical peels in the treatment area
Contraindicated for laser treatment, or is unable or unwilling to avoid excessive sun exposure or tanning bed use
Known allergy to gold

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Merete Haedersdal, MD, PhD	Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lasercenter North		Aalborg		9220	Denmark
Department of Dermatology, Bispebjerg Hospital, Univ of Copenhagen

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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