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Trial record 8 of 350 for:    acne AND facial

Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 30, 2016
First Posted Date January 4, 2017
Last Update Posted Date January 4, 2017
Study Start Date January 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 30, 2016)
Detection and analysis of facial P. acnes presence [ Time Frame: Day 0 and week 8 (optional) ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 30, 2016)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects will be male or female, ages 14-50. Healthy subjects and acne diagnosed subjects.
Condition Acne
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 30, 2016)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03009903
Other Study ID Numbers MBC-CL-01-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 2 sites to be activated. Dr. Shapiro is considered as PI in both sites
Responsible Party MBcure Ltd
Study Sponsor MBcure Ltd
Collaborators Not Provided
Investigators
Principal Investigator: Jonathan Shapiro, MD Maccabi Healthcare Services, Israel
PRS Account MBcure Ltd
Verification Date December 2016