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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S5G4T-1 | Experimental | Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks. |
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| S5G4T-2 Vehicle Cream | Placebo Comparator | Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S5G4T-1 | Drug | Once a day topical cream |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sol-Gel | Rochester | New York | 14623 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37636253 | Derived | Bhatia ND, Werschler WP, Baldwin H, Sugarman J, Green LJ, Levy-Hacham O, Nov O, Ram V, Stein Gold L. Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From Two Phase III, Randomized, Vehicle-Controlled Trials. J Clin Aesthet Dermatol. 2023 Aug;16(8):34-40. |
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Participants were randomized to receive either S5G4T-1 (Encapsulated Benzoyl Peroxide [E-BPO] cream) or vehicle in a 2:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | S5G4T-1 | Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks. |
| FG001 | S5G4T-2 Vehicle Cream | Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The intent-to-treat (ITT) population consisted of all randomized participants who were dispensed study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | S5G4T-1 | Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks. |
| BG001 | S5G4T-2 Vehicle Cream | Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Number | Percentage of Participants | Baseline through Week 12 |
|
Baseline (Day 0) through end of study (Week 12)
Safety population included randomized participants who were presumed to have used the study drug at least once and who provided at least 1 post-baseline safety evaluation. The total number of participants in the safety population differs from the Participant Flow because one participant who was randomized to E-BPO Cream actually received Vehicle Cream. The safety analyses counted this participant in the Vehicle Cream group since participants were analyzed based on actual study drug received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | S5G4T-1 | Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sol-Gel | Sol-Gel Technologies, Ltd. | 972-8-9313433 | info@sol-gel.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 24, 2018 | Dec 13, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 2, 2019 | Nov 9, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| S5G4T-2 | Drug | Once a day topical cream |
|
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| Baseline, Week 12 |
| Protocol Violation |
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| Withdrawal by Subject |
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| Other Than Specified |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline Inflammatory Lesion Count | Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 millimeter (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). | Mean | Standard Deviation | Lesions |
|
| Baseline Investigator's Global Assessment (IGA) | Investigator's Global Assessment (IGA), where Investigator's rated the participant's acne from 0 (Clear) to 4 (Severe). A higher score indicated an increase in severity of facial acne. | Number | participants |
|
| OG001 |
| S5G4T-2 Vehicle Cream |
Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks. |
|
|
| Primary | 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. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Inflammatory Lesions | Baseline, Week 12 |
|
|
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| Secondary | 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. | The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values. | Posted | Least Squares Mean | Standard Deviation | Percent Change | Baseline, Week 12 |
|
|
|
| 0 |
| 248 |
| 1 |
| 248 |
| 13 |
| 248 |
| EG001 | S5G4T-2 Vehicle Cream | Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks. | 0 | 121 | 0 | 121 | 12 | 121 |
| Sinusitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Application site pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Application site erythema | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.