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NCT02815332 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Acne Vulgaris, sponsored by BioPharmX.

Completed
Registry status
Phase 2
Development phase
225
Enrollment target
15
Study locations

NCT02815332 is a Phase 2 study of Acne Vulgaris that has completed, run by BioPharmX. The registered enrollment target is 225 participants, below the 272-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (17% lower). The trial reports 15 study locations across 11 states.

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The verdict

NCT02815332, a Phase 2 study of Acne Vulgaris, has completed, sponsored by BioPharmX.

COMPLETED
Registry status
Phase 2
Development phase
225 participants
Enrollment target
15
Study locations

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 Studied

Acne Vulgaris

Interventions

  • DRUG BPX-01 1% Minocycline Topical Gel
  • DRUG BPX-01 2% Minocycline Topical Gel
  • DRUG BPX-01 Vehicle Topical Gel

Study Locations (15)

Texas

  • - Pflugerville
  • - Plano
  • - San Antonio

Florida

  • - Coral Gables
  • - Lake Mary

Tennessee

  • - Murfreesboro
  • - Nashville

California

  • - Santa Monica

Georgia

  • - Newnan

Kentucky

  • - Louisville

Nevada

  • - Las Vegas

New Jersey

  • - Montclair

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2016-08
Est. Completion 2017-03-24
Phase Phase 2

Sponsor

BioPharmX

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02815332

The ClinicalTrials.gov registry entry for NCT02815332 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (17% lower). The listed sponsor is BioPharmX, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 3 interventions - of which BPX-01 1% Minocycline Topical Gel is the first listed.

NCT02815332 reports 15 study locations spanning 11 distinct geographic areas - top geographies include Texas, Florida, Tennessee.

Frequently Asked Questions

What is clinical trial NCT02815332 about?

NCT02815332 is a clinical study titled "BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris". 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. Le...

What is the current status of trial NCT02815332?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2016-08. Estimated completion is 2017-03-24.

What conditions does trial NCT02815332 study?

This clinical trial studies the following conditions: Acne Vulgaris.

What interventions are being tested in trial NCT02815332?

The interventions under investigation include: BPX-01 1% Minocycline Topical Gel (DRUG), BPX-01 2% Minocycline Topical Gel (DRUG), BPX-01 Vehicle Topical Gel (DRUG).

Who is sponsoring clinical trial NCT02815332?

This trial is sponsored by BioPharmX, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02815332 being conducted?

This trial has 15 study locations across California, Florida, Georgia, Kentucky, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.