Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans

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.

Study Overview

• Status: Unknown
• Conditions: Acne

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: MBcure Ltd
• Investigators: Principal Investigator: Jonathan Shapiro, MD, Maccabi Healthcare Services, Israel

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: December 30, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: December 30, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: MBC-CL-01-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 2 sites to be activated. Dr. Shapiro is considered as PI in both sites