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Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage

M

MBcure

Status

Unknown

Conditions

Acne

Study type

Observational

Funder types

Industry

Identifiers

NCT03009903
MBC-CL-01-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

14 to 50 years old

Volunteers

Accepts 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

Trial design

400 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Jonathan Shapiro, MD

Data sourced from clinicaltrials.gov

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