NCT03564119

A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Sol-Gel Technologies, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

Detailed description

In this Phase 3, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.

Conditions

• Papulopustular Rosacea

Interventions

Type	Name	Description
DRUG	S5G4T-1	Once a day topical cream
DRUG	S5G4T-2	Once a day topical cream

Timeline

• Start date: 2018-06-21
• Primary completion: 2019-06-10
• Completion: 2019-06-10
• First posted: 2018-06-20
• Last updated: 2021-12-15
• Results posted: 2021-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study