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A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea

NCT03276936 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2022-01-18

Study results available
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Summary

The primary objective is to show that open-label extended treatment with FMX103 1.5%, for up to an additional 40 weeks, is safe and well tolerated.

Conditions

  • Papulopustular Rosacea

Interventions

DRUG

FMX103 1.5%

FMX103 1.5% minocycline foam

Sponsors & Collaborators

  • Vyne Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2019-01-03
Completion
2019-01-15
FDA Drug
Yes

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 NCT03276936 on ClinicalTrials.gov