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Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

Primary Purpose

Acne

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
MBcure Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Acne

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

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

    First Posted
    December 30, 2016
    Last Updated
    December 30, 2016
    Sponsor
    MBcure Ltd
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    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

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