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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03009903

Enrollment

400

Registered

2017-01-04

Start date

2017-01-31

Completion date

2017-10-31

Last updated

2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

14 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactJonathan Shapiro, MD

jonmidi@gmail.com972.50.5759516

Outcome results