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

The objective of this study is to evaluate the comparative reduction of Propionibacterium
acnes (P. acnes) in-vivo following once daily topical administration of BPX-01 Minocycline
1% Topical Gel or BPX-01 Vehicle control Gel.

A secondary objective is to assess the tolerance of the treatment regimen versus a vehicle
control. Safety laboratory data (chemistry and hematology) and plasma levels of minocycline
are also of significant interest to the sponsor.

This is a single center, randomized, double blind, two-cell, vehicle controlled P. acnes
study. All subjects will be randomized 2:1 to 1% BPX-01 or vehicle control to be applied as
a topical gel once daily for four (4) weeks.

This is a six (6) week study with a four (4) week treatment period and a two (2) week post
treatment follow up visit. The clinical endpoint is in-vivo quantification of P.acnes. The
safety/tolerance endpoints are; observer reported: erythema, scaling-peeling, edema, and
subject reported: tightness, burning-stinging, and itching. Plasma levels of minocycline and
basic hematology and chemistry laboratory values will be collected.

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