Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage
Primary Purpose
Acne
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Acne
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
P. acne subjects
None P. acne subjects
Arm Description
14-50 year of age, P. acne diagnosed subjects
14-50 year of age, none P. acne diagnosed subjects
Outcomes
Primary Outcome Measures
Detection and analysis of facial P. acnes presence
Secondary Outcome Measures
Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03009903
Brief Title
Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage
Official Title
Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans
Study Type
Observational
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MBcure Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
7. Study Design
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
P. acne subjects
Arm Description
14-50 year of age, P. acne diagnosed subjects
Arm Title
None P. acne subjects
Arm Description
14-50 year of age, none P. acne diagnosed subjects
Primary Outcome Measure Information:
Title
Detection and analysis of facial P. acnes presence
Time Frame
Day 0 and week 8 (optional)
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Study Population Description
Subjects will be male or female, ages 14-50. Healthy subjects and acne diagnosed subjects.
Sampling Method
Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Shapiro, MD
Phone
972.50.5759516
Email
jonmidi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Shapiro, MD
Organizational Affiliation
Maccabi Healthcare Services, Israel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
2 sites to be activated. Dr. Shapiro is considered as PI in both sites
Learn more about this trial
Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage
We'll reach out to this number within 24 hrs