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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPX-01, 1% Topical Gel | Experimental | BPX-01, 1% Topical Gel; applied once daily to the face for four weeks. |
|
| BPX-01, Vehicle Gel | Placebo Comparator | BPX-01, Vehicle Gel; applied once daily to the face for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPX-01, 1% Topical Gel | Drug | topical gel, applied to the forehead, cheeks, nose and chin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Lessin, MD | KGL, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGL Skin Study Center | Broomall | Pennsylvania | 19008 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | BPX-01, Vehicle Gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol population included all subjects with evaluable data and no major protocol violations. | Posted | Mean | Standard Deviation | log change in colony forming units | Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline. |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AnnaMarie Daniels | BioPharmX, Inc. | 310-701-2080 | amdaniels@biopharmx.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| BPX-01 Vehicle Gel | Drug | topical gel, applied to the forehead, cheeks, nose and chin |
|
|
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 4 |
| 22 |
| EG001 | 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 | 0 | 11 | 1 | 11 | 1 | 11 |
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinus infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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