Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

Acne Clinical Trial

Official title:

Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03009903
• Other study ID #: MBC-CL-01-2016
• Status: Not yet recruiting
• Phase: N/A
• First received: December 30, 2016
• Last updated: December 30, 2016
• Start date: January 2017
• Est. completion date: October 2017

Study information

• Verified date: December 2016
• Source: MBcure Ltd
• Contact: Jonathan Shapiro, MD
• Phone: 972.50.5759516
• Email: jonmidi[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 50 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Acne

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MBcure Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection and analysis of facial P. acnes presence		Day 0 and week 8 (optional)	No
Secondary	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	No