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

Sol-Gel Technologies

Status and phase: Terminated; Phase 3

Conditions: Papulopustular Rosacea

Treatments: Drug: S5G4T-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03564145

SGT-54-07

Details and patient eligibility

About

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).

Full 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.

Enrollment: 547 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for the extension study.
2. Participants must complete 12 weeks or within the Week 12 window time (± 4 days) of the double-blind treatment period of Study SGT-54-01 or Study SGT-54-02 and missed not more than 1 visit of Visits 3, 4 or 5 in Study SGT-54-01 or Study SGT-54-02.

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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547 participants in 1 patient group

S5G4T-1

Experimental group

Description:

Participants will topically apply S5G4T-1 cream, once daily to face for 40 weeks.

Treatment:

Drug: S5G4T-1