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

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ClinicalTrials.gov Identifier: NCT02695446
Recruitment Status : Completed
First Posted : March 1, 2016
Results First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acne Drug: Minocycline Phase 4

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  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline
Study Start Date : March 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

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Arm Intervention/treatment
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 Name: MCN




Primary Outcome Measures :
  1. Plasma Minocycline Level [ Time Frame: Assessed at week 2 and week 4; reported at week 4 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695446


Locations
United States, Pennsylvania
KGL Skin Study Center
Broomall, Pennsylvania, United States, 19008
Sponsors and Collaborators
BioPharmX, Inc.
Investigators
Principal Investigator: Stuart Lessin, MD KGL, Inc.

Responsible Party: BioPharmX, Inc.
ClinicalTrials.gov Identifier: NCT02695446     History of Changes
Other Study ID Numbers: BPX-01-C01
First Posted: March 1, 2016    Key Record Dates
Results First Posted: September 14, 2017
Last Update Posted: September 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents