Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage
- Conditions
- Acne
- Registration Number
- NCT03009903
- Lead Sponsor
- MBcure Ltd
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection and analysis of facial P. acnes presence Day 0 and week 8 (optional)
- Secondary Outcome Measures
Name Time Method 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