NCT03564145

A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

A Multi-Center, Open-Label, Long-Term Safety Study of S5G4T-1 to Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: Sol-Gel Technologies, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study SGT-54-02 (NCT03564119).

Detailed description

This is a long-term safety study for participants who completed either study SGT-54-01 or SGT-54-02. Participants will be admitted into the study only after a written informed consent has been obtained and not missing more than 1 visit of Visits 3, 4 or 5 in these studies. Eligible participants for enrollment will apply the study product, S5G4T-1, daily for up to an additional 40 weeks for a total of up to 52 weeks for some participants.

Conditions

• Papulopustular Rosacea

Interventions

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

Timeline

• Start date: 2018-09-12
• Primary completion: 2019-11-13
• Completion: 2019-11-13
• 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