BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: BioPharmX, Inc.
• Treatments: Minocycline

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