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

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.

Study Overview

• Status: Completed
• Conditions: Acne
• Intervention / Treatment: Drug: Minocycline

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Kgl Skin Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BioPharmX, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 1, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: BPX-01-C01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO