A Study of S5G4T-1 in the Treatment of Papular-Pustular Rosacea

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sol-Gel Technologies, Ltd.

Criteria

Inclusion Criteria:

1. Patient must sign an Institutional Review Board (IRB) approved written informed consent for this study.

2. Male and female 18 years of age and older.

3. Patients must have clinical diagnosis of moderate to severe rosacea.

4. Have a minimum total of 15.

5. Have two nodules or less .

Exclusion Criteria:

1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at baseline or screening visits.

2. Presence of more than 2 facial nodules or any nodule greater than 1 cm.

3. Current or past ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.