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

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

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

Study Overview

• Status: Completed
• Conditions: Papulopustular Rosacea
• Intervention / Treatment: Drug: S5G4T-1; Drug: S5G4T-2

Detailed Description

In this Phase 3, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants 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 Type: Interventional
• Enrollment (Actual): 372
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14623
      • Sol-Gel

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Participants 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. Participants must have clinical diagnosis of moderate to severe rosacea.
4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
5. Have 2 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 centimeter (cm).
3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S5G4T-1; Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.	Drug: S5G4T-1; Once a day topical cream; Other Names: Encapsulated benzoyl peroxide (E-BPO) cream
Placebo Comparator: S5G4T-2 Vehicle Cream; Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.	Drug: S5G4T-2; Once a day topical cream; Other Names: Vehicle cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Inflammatory Lesion Counts at Week 12	Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.	Baseline, Week 12
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12	Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)". Please note, the Percentage of Participants multiplied by the Overall Number of Participants Analyzed does not equal a whole number because missing efficacy data was based on estimation using the method of Markov Chain Monte Carlo (MCMC) imputation.	Baseline through Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12	Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an ANCOVA with factors of treatment and analysis center and Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Sol-Gel Technologies, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): June 10, 2019
• Study Completion (Actual): June 10, 2019

Study Registration Dates

• First Submitted: June 10, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: papulopustular rosacea
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Dermatologic Agents; Benzoyl Peroxide
• Other Study ID Numbers: SGT-54-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No