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Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

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ClinicalTrials.gov Identifier: NCT03009903
Recruitment Status : Unknown
Verified December 2016 by MBcure Ltd.
Recruitment status was:  Not yet recruiting
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Acne

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Official Title: Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans
Study Start Date : January 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Group/Cohort
P. acne subjects
14-50 year of age, P. acne diagnosed subjects
None P. acne subjects
14-50 year of age, none P. acne diagnosed subjects



Primary Outcome Measures :
  1. Detection and analysis of facial P. acnes presence [ Time Frame: Day 0 and week 8 (optional) ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects will be male or female, ages 14-50. Healthy subjects and acne diagnosed subjects.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009903


Contacts
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Contact: Jonathan Shapiro, MD 972.50.5759516 jonmidi@gmail.com

Sponsors and Collaborators
MBcure Ltd
Investigators
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Principal Investigator: Jonathan Shapiro, MD Maccabi Healthcare Services, Israel

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Responsible Party: MBcure Ltd
ClinicalTrials.gov Identifier: NCT03009903     History of Changes
Other Study ID Numbers: MBC-CL-01-2016
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 2 sites to be activated. Dr. Shapiro is considered as PI in both sites
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases