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BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris

NCT02815332 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2017-04-14

No results posted yet for this study

Summary

This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled study.

Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy.

Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and collection of adverse events.

Conditions

  • Acne Vulgaris

Interventions

DRUG

BPX-01 1% Minocycline Topical Gel

Approximately 1 gram applied once daily for 12 weeks

DRUG

BPX-01 2% Minocycline Topical Gel

Approximately 1 gram applied once daily for 12 weeks

DRUG

BPX-01 Vehicle Topical Gel

Approximately 1 gram applied once daily for 12 weeks

Sponsors & Collaborators

  • BioPharmX, Inc.

    lead INDUSTRY

Principal Investigators

  • AnnaMarie Daniels · Sponsor (BioPharmX)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-03-24
Completion
2017-03-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02815332 on ClinicalTrials.gov