Acne Vulgaris
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGBPX-01, 1% Topical Gel
topical gel, applied to the forehead, cheeks, nose and chin
DRUGBPX-01 Vehicle Gel
topical gel, applied to the forehead, cheeks, nose and chin
Sponsors
BioPharmX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes | Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline. | P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BPX-01, 1% Topical Gel BPX-01, 1% Topical Gel; applied once daily to the face for four weeks.
BPX-01, 1% Topical Gel: topical gel, applied to the forehead, cheeks, nose and chin | 22 |
| BPX-01, Vehicle Gel BPX-01, Vehicle Gel; applied once daily to the face for four weeks.
BPX-01 Vehicle Gel: topical gel, applied to the forehead, cheeks, nose and chin | 11 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | non-compliance | 1 | 1 |
Baseline characteristics
| Characteristic | BPX-01, 1% Topical Gel | Total | BPX-01, Vehicle Gel |
|---|---|---|---|
| Age, Continuous | 32 years | 32 years | 34 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 29 Participants | 9 Participants |
| Region of Enrollment United States | 22 participants | 33 participants | 11 participants |
| Sex: Female, Male Female | 16 Participants | 24 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 11 |
| other Total, other adverse events | 4 / 22 | 1 / 11 |
| serious Total, serious adverse events | 0 / 22 | 1 / 11 |
Outcome results
Primary
Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes
P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.
Time frame: Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.
Population: Per protocol population included all subjects with evaluable data and no major protocol violations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BPX-01, 1% Topical Gel | Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes | -1.0376 log change in colony forming units | Standard Deviation 0.5479 |
| BPX-01, Vehicle Gel | Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes | -0.4614 log change in colony forming units | Standard Deviation 0.4042 |