MedTrace Logo

Study to Evaluate the Safety and Efficacy of Topical Minocycline Gel in Patients With Papulopustular Rosacea

NCT03263273 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2019-11-08

No results posted yet for this study

Summary

To evaluate the efficacy of once-daily application of 1% and 3% HY01 Topical Gel, as assessed by the change in inflammatory lesion count from baseline over the 12-week treatment period in patients with moderate-to-severe papulopustular rosacea.

Conditions

  • Rosacea
  • Papulopustular Rosacea

Interventions

DRUG

1% Topical Minocycline Gel

Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention

DRUG

3% Topical Minocycline Gel

Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention

OTHER

Topical Vehicle Gel

Treating Papulopustular Rosacea while monitoring for safety and efficacy of the vehicle intervention

Sponsors & Collaborators

  • Hovione Scientia Limited

    lead INDUSTRY

Principal Investigators

  • Sunil S Dhawan, MD · Center for Dermatology Clinical Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2019-03-01
Completion
2019-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03263273 on ClinicalTrials.gov