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

NCT ID: NCT02695446

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Acne

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral ER Minocycline - Up to 2mg/kg

Oral extended release minocycline - up to 2mg/kg once a day for 30 days.

Group Type: OTHER

Minocycline

Intervention Type: DRUG

Oral extended release minocycline

Interventions

Minocycline

Oral extended release minocycline

Intervention Type: DRUG

Other Intervention Names

MCN

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioPharmX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart Lessin, MD

Role: PRINCIPAL_INVESTIGATOR

KGL, Inc.

Locations

KGL Skin Study Center

Broomall, Pennsylvania, United States

Countries

United States

Other Identifiers

BPX-01-C01

Identifier Type: -

Identifier Source: org_study_id