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

Acne Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02695446
• Other study ID #: BPX-01-C01
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 18, 2016
• Last updated: March 24, 2016
• Start date: March 2016
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: BioPharmX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 40 Years

Eligibility

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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne

Intervention

Drug:
• Minocycline
Oral extended release minocycline

Locations

Country	Name	City	State
United States	KGL Skin Study Center	Broomall	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
BioPharmX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Skin/Dermal levels of minocycline detected		2 weeks, 4 weeks	No