Evaluation and Detection of Facial Propionibacterium Acne... | NCT03009903

Studies
Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

NCT03009903

Sponsor

MBcure Ltd

Status

Unknown status

Last Update Posted

Jan 4, 2017Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Acne

Interventions

Not provided

Countries

Not provided

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

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Jul 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Dec 30, 2016

First Submission Date that Met QC Criteria

Dec 30, 2016

First Posted Date

Jan 4, 2017Estimated

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

Dec 30, 2016

Last Update Posted Date

Jan 4, 2017Estimated

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 multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects.

Detailed Description

This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects. An additional P. acnes visual detection method (VISIOPOR ® PP34N) will be used in this study as per PI decision to explore whether there is a correlation between P. acnes bacterial presence and fluorescent signal.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
P. acne subjects		14-50 year of age, P. acne diagnosed subjects
None P. acne subjects		14-50 year of age, none P. acne diagnosed subjects

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection and analysis of facial P. acnes presence		Day 0 and week 8 (optional)

Secondary Outcomes

Measure	Description	Time Frame
Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.		Day 0 and week 8 (optional

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults between 14 to 50 years of age inclusive at the time of signing the informed consent
Able to provide written informed consent
Subjects who are willing to undergo pore strip treatment using the cosmetically acceptable pore strip product
Subjects who are willing to provide comprehensive demographic data using questionnaires

Exclusion Criteria:

Unwilling or unable to follow the procedures outlined in the protocol
Subjects treated with isotretinoin or tretinion during the 6 months prior to visit 1
Subjects treated with immunosuppressant agents
Pregnant subjects

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Subjects will be male or female, ages 14-50. Healthy subjects and acne diagnosed subjects.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jonathan Shapiro, MD	Contact	972.50.5759516		jonmidi@gmail.com

Overall Officials

Name	Affiliation	Role
Jonathan Shapiro, MD	Maccabi Healthcare Services, Israel	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

2 sites to be activated. Dr. Shapiro is considered as PI in both sites

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