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

NCT02695446 | Completed Phase 4 Results

• 1 other identifier: BPX-01-C01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

• Plasma Minocycline Level

  Assessed at week 2 and week 4; reported at week 4

Secondary Outcomes (1)

• Skin/Dermal Levels of Minocycline

  Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules

Study Arms (1)

Oral ER Minocycline - Up to 2mg/kg

OTHER

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

Drug: Minocycline

Interventions

Minocycline DRUG

Oral extended release minocycline

Also known as: MCN

Oral ER Minocycline - Up to 2mg/kg

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioPharmX, Inc.: lead

Study Sites (1)

KGL Skin Study Center

Broomall, Pennsylvania, 19008, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: AnnaMarie Daniels
• Organization: BioPharmX, Inc.

amdaniels@biopharmx.com

310-701-2080

Study Officials

• Stuart Lessin, MD

  KGL, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 1, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 14, 2017
• Results First Posted: September 14, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)