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Completed

NCT Number: NCT02695446

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

KGL Skin Study Center

Broomall, Pennsylvania, 19008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minocycline

Drug

Oral extended release minocycline

Other names: MCN

Primary outcomes

  1. Plasma Minocycline Level

    Time frame: Assessed at week 2 and week 4; reported at week 4

Secondary outcomes

  1. Skin/Dermal Levels of Minocycline

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

Sponsors and collaborators

Lead sponsor

BioPharmX, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2016
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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