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

Phase 4

Completed

• Conditions: Acne
• Interventions: Drug: Minocycline

• Registration Number: NCT02695446
• Lead Sponsor: BioPharmX, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-29
• Study Start: 2016-03
• Study First Posted: 2016-03-01
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Results First Submitted: 2017-07-17
• Status Verified: 2017-08
• Results First Submitted QC: 2017-08-16
• Last Update Submitted: 2017-08-16
• Results First Posted: 2017-09-14
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral ER Minocycline - Up to 2mg/kg	Minocycline	Oral extended release minocycline - up to 2mg/kg once a day for 30 days.

Primary Outcome Measures

Name	Time	Method
Plasma Minocycline Level	Assessed at week 2 and week 4; reported at week 4

Secondary Outcome Measures

Name	Time	Method
Skin/Dermal Levels of Minocycline	Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules

Trial Locations

Locations (1)

KGL Skin Study Center; 🇺🇸 Broomall, Pennsylvania, United States