Papulopustular Rosacea
Conditions
Keywords
papulopustular rosacea
Brief summary
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
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.
Sponsors
Sol-Gel Technologies, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 | Baseline through 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. |
| Change From Baseline in Inflammatory Lesion Counts at Week 12 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | Baseline, 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. |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomized to receive either S5G4T-1 (Encapsulated Benzoyl Peroxide \[E-BPO\] cream) or vehicle in a 2:1 ratio.
Participants by arm
| Arm | Count |
|---|---|
| S5G4T-1 Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks. | 250 |
| S5G4T-2 Vehicle Cream Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks. | 122 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Other Than Specified | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 4 |
Baseline characteristics
| Characteristic | S5G4T-1 | Total | S5G4T-2 Vehicle Cream |
|---|---|---|---|
| Age, Continuous | 49.5 Years STANDARD_DEVIATION 14.04 | 50.1 Years STANDARD_DEVIATION 13.59 | 51.5 Years STANDARD_DEVIATION 12.55 |
| Baseline Inflammatory Lesion Count | 29.8 Lesions STANDARD_DEVIATION 14 | 29.0 Lesions STANDARD_DEVIATION 13.72 | 27.5 Lesions STANDARD_DEVIATION 13.04 |
| Baseline Investigator's Global Assessment (IGA) 0 - Clear | 0 participants | 0 participants | 0 participants |
| Baseline Investigator's Global Assessment (IGA) 1 - Almost Clear | 0 participants | 0 participants | 0 participants |
| Baseline Investigator's Global Assessment (IGA) 2 - Mild | 0 participants | 0 participants | 0 participants |
| Baseline Investigator's Global Assessment (IGA) 3 - Moderate | 227 participants | 339 participants | 112 participants |
| Baseline Investigator's Global Assessment (IGA) 4 - Severe | 23 participants | 33 participants | 10 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants | 85 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants | 287 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 28 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 220 Participants | 330 Participants | 110 Participants |
| Sex: Female, Male Female | 181 Participants | 268 Participants | 87 Participants |
| Sex: Female, Male Male | 69 Participants | 104 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 248 | 0 / 121 |
| other Total, other adverse events | 13 / 248 | 12 / 121 |
| serious Total, serious adverse events | 1 / 248 | 0 / 121 |
Outcome results
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.
Time frame: Baseline, Week 12
Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| S5G4T-1 | Change From Baseline in Inflammatory Lesion Counts at Week 12 | -20.3 Inflammatory Lesions | Standard Deviation 9.64 |
| S5G4T-2 Vehicle Cream | Change From Baseline in Inflammatory Lesion Counts at Week 12 | -13.3 Inflammatory Lesions | Standard Deviation 9.6 |
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.
Time frame: Baseline through Week 12
Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| S5G4T-1 | Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 | 50.1 Percentage of Participants |
| S5G4T-2 Vehicle Cream | Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 | 25.9 Percentage of Participants |
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.
Time frame: Baseline, Week 12
Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| S5G4T-1 | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | -69.4 Percent Change | Standard Deviation 32.66 |
| S5G4T-2 Vehicle Cream | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | -46.0 Percent Change | Standard Deviation 32.31 |