Rochester, New York 14623

  • Papulopustular Rosacea

Purpose:

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


Study summary:

In this Phase 3, double blind, vehicle controlled study, patients will be admitted into this multi center, double blind, randomized, vehicle controlled, parallel group pivotal study only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female patients 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.


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.


NCT ID:

NCT03564119


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Rochester, New York 14623
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 23, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.