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

• ClinicalTrials.gov Identifier: NCT03448939
• Recruitment Status: Completed
• First Posted: February 28, 2018
• Last Update Posted: December 2, 2019
• Sponsor: Sol-Gel Technologies, Ltd.
• Information provided by (Responsible Party): Sol-Gel Technologies, Ltd.

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Papulopustular Rosacea	Drug: S5G4T-1; Drug: S5G4T-2	Phase 3

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 361 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
• Actual Study Start Date: June 30, 2018
• Actual Primary Completion Date: May 31, 2019
• Actual Study Completion Date: May 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: S5G4T-1; topical cream	Drug: S5G4T-1; once a day topical cream
Placebo Comparator: S5G4T-2; topical cream	Drug: S5G4T-2; once a day topical cream

Outcome Measures

Primary Outcome Measures :

1. Investigator's Global Assessment (IGA) [ Time Frame: week 12 ]
   Proportion of patients with the primary measure of success "Clear" (0) or "Almost clear" (1) in the IGA relative to Baseline at Week 12.
2. Lesion count [ Time Frame: week 12 ]
   Absolute change in inflammatory lesion counts from baseline to Week 12.

Secondary Outcome Measures :

1. Percent change in lesion count [ Time Frame: week 12 ]
   Percent change in inflammatory lesion count at Week 12

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Florida

Sol-Gel site 501

Tampa, Florida, United States, 33607

Sponsors and Collaborators

Sol-Gel Technologies, Ltd.

More Information

• Responsible Party: Sol-Gel Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT03448939
• Other Study ID Numbers: SGT-54-01
• First Posted: February 28, 2018
• Last Update Posted: December 2, 2019
• Last Verified: November 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sol-Gel Technologies, Ltd.:

papulopustular rosacea

Additional relevant MeSH terms:

Rosacea; Skin Diseases