Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline

Conditions
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Acne

Intervention / Treatment
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* Drug: Minocycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Otherwise healthy male and female subjects 14 to 40 years of age Moderate to severe inflammatory facial acne vulgaris (EGSA score of 3-5) Subjects not using oral or topical antibiotic products for at least 30 days prior to study entry and willing to refrain from use of oral and topical antibiotics for the duration of study participation Subjects not currently using and willing to refrain from use of other topical acne products for the duration of study participation Exclusion Criteria: Mild, non-inflammatory or nodular acne vulgaris Have current or previous skin cancer Have a history of skin disease or presence of skin condition the PI believes would interfere with the study Females who report that they are pregnant, planning a pregnancy during the study period or breastfeeding Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results Participation in any clinical study within the previous 30 days or plan concurrent participation in other studies

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oral ER Minocycline - Up to 2mg/kg<br>Oral extended release minocycline - up to 2mg/kg once a day for 30 days. | Drug: Minocycline<br>* Oral extended release minocycline<br>* Other names: MCN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Minocycline Level |  | Assessed at week 2 and week 4; reported at week 4 | 

Secondary Outcome Measures

| Outcome Measure | 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 |