NCT02695446

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: BioPharmX, Inc. · Industry
• Sex: All
• Age: 14 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Minocycline	Oral extended release minocycline

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2016-03-01
• Last updated: 2017-09-14
• Results posted: 2017-09-14

Locations

1 site across 1 country: United States