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 2021-12-14.
Sponsored by Sol-Gel Technologies, Ltd. · Phase 3, Interventional, and Treatment
To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.
In this Phase 3, double-blind, 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.
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)".
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 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
| Milestone | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| Started | 243 | 118 |
| Received at least 1 dose of study drug | 239 | 113 |
| Completed | 222 | 107 |
| Not completed | 21 | 11 |
| Withdrew: Adverse event | 5 | 1 |
| Withdrew: Lost to follow-up | 6 | 6 |
| Withdrew: Pregnancy | 1 | 1 |
| Withdrew: Withdrawal by subject | 9 | 3 |
Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)".
| 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 | 43.5 | 16.1 |
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 | -17.4 ± 9.30 | -9.5 ± 9.45 |
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.
| Percent Change | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | -68.2 ± 36.94 | -38.3 ± 37.02 |
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 | 0/239 (0%) | 0/239 (0%) | 13/239 (5.4%) |
| S5G4T-2 Vehicle Cream | 0/113 (0%) | 1/113 (0.9%) | 5/113 (4.4%) |
| Event | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| Femur fractureInjury, poisoning and procedural complications | 0/239 | 1/113 |
| Event | S5G4T-1 | S5G4T-2 Vehicle Cream |
|---|---|---|
| Application site erythemaGeneral disorders | 8/239 | 2/113 |
| NasopharyngitisInfections and infestations | 6/239 | 1/113 |
| Application site painGeneral disorders | 5/239 | 2/113 |
| Upper respiratory tract infectionInfections and infestations | 3/239 | 2/113 |
| Application site papulesGeneral disorders | 0/239 | 2/113 |
| Application site pruritusGeneral disorders | 3/239 | 1/113 |
| Muscle strainInjury, poisoning and procedural complications | 3/239 | 0/113 |
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 | 52.8 ± 13.21 | 52.4 ± 13.26 | 52.7 ± 13.21 |
| Sex: Female, Male(Participants) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| Female | 183 | 83 | 266 |
| Male | 60 | 35 | 95 |
| Ethnicity (NIH/OMB)(Participants) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| Hispanic or Latino | 86 | 39 | 125 |
| Not Hispanic or Latino | 156 | 77 | 233 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 9 | 2 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 233 | 116 | 349 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Baseline Inflammatory Lesion Count(lesions) | S5G4T-1 | S5G4T-2 Vehicle Cream | Total |
|---|---|---|---|
| Mean | 25.7 ± 11.07 | 26.3 ± 12.45 | 25.9 ± 11.52 |
| 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 | 210 | 104 | 314 |
| 4 - Severe | 33 | 14 | 47 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sol-Gel Technologies, Ltd.