Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

MBcure Ltd400 enrolled

Overview

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.

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

400

Conditions

Acne

Eligibility

Sex: ALLMin age: 14 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Detection and analysis of facial P. acnes presence

Time frame: Day 0 and week 8 (optional)

Secondary Outcomes

Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.

Time frame: Day 0 and week 8 (optional

Central Contacts

Jonathan Shapiro, MD

CONTACT

972.50.5759516 jonmidi@gmail.com

Data from ClinicalTrials.gov

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