A Phase 3 interventional study of S5G4T-1 and S5G4T-2 in Papulopustular Rosacea, sponsored by Sol-Gel Technologies, Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by Sol-Gel Technologies, Ltd. · Phase 3, Interventional, and Treatment
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.
225 studies on the registry are indexed under Rosacea; 19 are open to participants now.
This study's enrollment of 372 is above the median of 61 across 195 interventional studies indexed under Rosacea.
Browse Rosacea studies →Sol-Gel Technologies, Ltd. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.
Drug: S5G4T-1
Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Drug: S5G4T-2
Once a day topical cream
Also known as: Encapsulated benzoyl peroxide (E-BPO) cream
Once a day topical cream
Also known as: Vehicle cream
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.
Time frame: 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.
Time frame: Baseline, Week 12
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.
Time frame: Baseline, Week 12
| Milestone | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| Started | 250 | 122 |
| Received at least 1 dose of study drug | 249 | 120 |
| Completed | 235 | 113 |
| Not completed | 15 | 9 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Lost to follow-up | 1 | 4 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 9 | 4 |
| Withdrew: Other than specified | 0 | 1 |
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.
| Percentage of Participants | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 | 50.1 | 25.9 |
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.
| Inflammatory Lesions | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| Change From Baseline in Inflammatory Lesion Counts at Week 12 | -20.3 ± 9.64 | -13.3 ± 9.60 |
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.
| Percent Change | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | -69.4 ± 32.66 | -46.0 ± 32.31 |
Collected over Baseline (Day 0) through end of study (Week 12). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| S5G4T-1 | 0/248 (0%) | 1/248 (0.4%) | 13/248 (5.2%) |
| S5G4T-2 Vehicle Cream | 0/121 (0%) | 0/121 (0%) | 12/121 (9.9%) |
| Event | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| Spinal compression fractureInjury, poisoning and procedural complications | 1/248 | 0/121 |
| Event | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| NasopharyngitisInfections and infestations | 6/248 | 3/121 |
| Urinary tract infectionInfections and infestations | 2/248 | 3/121 |
| Application site painGeneral disorders | 6/248 | 0/121 |
| InfluenzaInfections and infestations | 2/248 | 2/121 |
| Upper respiratory tract infectionInfections and infestations | 2/248 | 2/121 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 1/248 | 2/121 |
| SinusitisInfections and infestations | 3/248 | 0/121 |
| Application site erythemaGeneral disorders | 3/248 | 0/121 |
| Application site pruritusGeneral disorders | 3/248 | 0/121 |
The intent-to-treat (ITT) population consisted of all randomized participants who were dispensed study drug.
| Age, Continuous(Years) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| Mean | 49.5 ± 14.04 | 51.5 ± 12.55 | 50.1 ± 13.59 |
| Sex: Female, Male(Participants) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| Female | 181 | 87 | 268 |
| Male | 69 | 35 | 104 |
| Ethnicity (NIH/OMB)(Participants) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| Hispanic or Latino | 55 | 30 | 85 |
| Not Hispanic or Latino | 195 | 92 | 287 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 20 | 8 | 28 |
| Native Hawaiian or Other Pacific Islander | 3 | 2 | 5 |
| Black or African American | 2 | 0 | 2 |
| White | 220 | 110 | 330 |
| More than one race | 5 | 0 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Baseline Inflammatory Lesion Count(Lesions) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| Mean | 29.8 ± 14.00 | 27.5 ± 13.04 | 29.0 ± 13.72 |
| Baseline Investigator's Global Assessment (IGA)(participants) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| 0 - Clear | 0 | 0 | 0 |
| 1 - Almost Clear | 0 | 0 | 0 |
| 2 - Mild | 0 | 0 | 0 |
| 3 - Moderate | 227 | 112 | 339 |
| 4 - Severe | 23 | 10 | 33 |
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Sol-Gel Technologies, Ltd.