BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: BPX-01, 1% Topical Gel; BPX-01 Vehicle Gel
Intervention description: topical gel, applied to the forehead, cheeks, nose and chin; topical gel, applied to the forehead, cheeks, nose and chin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate
      the comparative reduction of Propionibacterium acnes in-vivo following once daily topical
      administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be a healthy, adult male and/or female volunteer 18 to 40 years of age with no past or
             present history of any significant disease based on PI discretion;

          2. If female, must be post-menopausal, surgically sterile, or using effective birth
             control methods with a negative urine pregnancy test at the Screening and Baseline
             visits (female subjects of childbearing potential only);

          3. Show a high degree of fluorescence of the face under a Wood's lamp at the screening
             visit.

          4. Be willing to refrain from using antimicrobial topical products for the duration of
             study participation;

          5. Be willing to return to the study center for all study visits;

          6. Be willing to follow all study instructions and adhere to study restrictions;

          7. Provide informed consent to the study procedures and restrictions

        Exclusion Criteria:

          1. Have a history of skin disease or presence of skin condition the PI believes would
             interfere with the study;

          2. Females who report that they are pregnant, planning a pregnancy or breastfeeding or
             those females who are of child bearing potential, that test positive with a urine
             pregnancy test;

          3. Have conditions or factors that the PI believes may affect the response of the skin or
             the interpretation of the results;

          4. Participated in any clinical study within the previous 30 days, be concurrently
             participating in other studies, or be involved in any aspect of test administration;

          5. Use of topical or systemic antibiotics or other products within the previous 4 weeks
             prior to baseline, that influence P. acnes counts;

          6. Are known to be allergic to any of the test product(s) or any components in the test
             product(s);

          7. Have a history of significant medical condition/disease that the PI believes may
             affect the response of the skin or the interpretation of the results;

          8. Has any other condition that, in the opinion of the Investigator or his designee,
             could interfere with the subject's ability to use the treatment as instructed, alter
             their treatment response, or affect their ability to complete the study