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The primary objective of this study is to evaluate the skin and plasma concentrations of minocycline in subjects undergoing treatment of acne vulgaris with oral extended release minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.
This will be an open label, non randomized, interventional pilot study evaluating the plasma and skin levels of minocycline in 10 subjects with moderate to severe acne vulgaris. Subjects with non inflammatory acne of nodular acne will not be enrolled. Subjects will be on an oral extended release minocycline regimen of up to 2mg/kg once a day for 4 weeks.
Steady state levels of minocycline in plasma and skin will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral ER Minocycline - Up to 2mg/kg | Other | Oral extended release minocycline - up to 2mg/kg once a day for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug | Oral extended release minocycline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Minocycline Level | Assessed at week 2 and week 4; reported at week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin/Dermal Levels of Minocycline | Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules |
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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 | Oral ER Minocycline - Up to 2mg/kg | Oral extended release minocycline - up to 2mg/kg once a day for 30 days. Minocycline: Oral extended release minocycline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral ER Minocycline - Up to 2mg/kg | Oral extended release minocycline - up to 2mg/kg once a day for 30 days. Minocycline: Oral extended release minocycline |
| 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 | Plasma Minocycline Level | Posted | Mean | Standard Deviation | ng/ml | Assessed at week 2 and week 4; reported at week 4 |
|
|
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 | Oral ER Minocycline - Up to 2mg/kg | Oral extended release minocycline - up to 2mg/kg once a day for 30 days. Minocycline: Oral extended release minocycline |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-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 |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Plasma Minocycline (ng/ml) | Mean | Full Range | ng/ml |
|
|
| Secondary | Skin/Dermal Levels of Minocycline | Posted | Mean | Full Range | ng/ml | Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |