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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Papulopustular Rosacea

Intervention / Treatment
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* Drug: S5G4T-1
* Drug: S5G4T-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study. Male and female 18 years of age and older. Participants must have clinical diagnosis of moderate to severe rosacea. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose. Have 2 nodules or less. Exclusion Criteria: 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. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm). Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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papulopustular rosacea