Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline
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|ClinicalTrials.gov Identifier: NCT02695446|
Recruitment Status : Completed
First Posted : March 1, 2016
Results First Posted : September 14, 2017
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acne||Drug: Minocycline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||May 2016|
Oral ER Minocycline - Up to 2mg/kg
Oral extended release minocycline - up to 2mg/kg once a day for 30 days.
Oral extended release minocycline
Other Name: MCN
- Plasma Minocycline Level [ Time Frame: Assessed at week 2 and week 4; reported at week 4 ]
- Skin/Dermal Levels of Minocycline [ Time Frame: Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695446
|United States, Pennsylvania|
|KGL Skin Study Center|
|Broomall, Pennsylvania, United States, 19008|
|Principal Investigator:||Stuart Lessin, MD||KGL, Inc.|