NCT03263273

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

A Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of 1% and 3% Topical MIinocycline Gel (HY01) in Patients With Papulopustular Rosacea

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Hovione Scientia Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-10-30
• Primary completion: 2019-03-01
• Completion: 2019-07-01
• First posted: 2017-08-28
• Last updated: 2019-11-08

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study