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Tetracycline Antibiotic

BPX-04 Active for Papulopustular Rosacea (PRISM Trial)

Phase 2
Waitlist Available
Research Sponsored by BioPharmX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights

PRISM Trial Summary

This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.

Eligible Conditions
  • Papulopustular Rosacea

PRISM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Inflammatory lesion count
Secondary outcome measures
Change in IGA

Side effects data

From 2017 Phase 2 trial • 22 Patients • NCT01746043
20%
Peripheral Neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Armodafinil+Minocycline
Minocycline
Armodafinil

PRISM Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BPX-04 ActiveExperimental Treatment1 Intervention
BPX-04 1% minocycline topical gel
Group II: BPX-04 VehiclePlacebo Group1 Intervention
BPX-04 topical gel vehicle

Find a Location

Who is running the clinical trial?

BioPharmX, Inc.Lead Sponsor
6 Previous Clinical Trials
351 Total Patients Enrolled
AnnaMarie DanielsStudy DirectorBioPharmX, Inc.
4 Previous Clinical Trials
315 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea
2018. "Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03667222.
All > Rosacea
~31 spots leftby Apr 2025
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