Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

NCT ID: NCT03009903

Last Updated: 2017-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Acne

Study Groups

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P. acne subjects

14-50 year of age, P. acne diagnosed subjects

No interventions assigned to this group

None P. acne subjects

14-50 year of age, none P. acne diagnosed subjects

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MBcure Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Shapiro, MD

Role: PRINCIPAL_INVESTIGATOR

Maccabi Healthcare Services, Israel

Central Contacts

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Jonathan Shapiro, MD

Role: CONTACT

972.50.5759516

Other Identifiers

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MBC-CL-01-2016

Identifier Type: -

Identifier Source: org_study_id

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