Trial Outcomes & Findings for A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea (NCT NCT03448939)
NCT ID: NCT03448939
Last Updated: 2021-12-14
Results Overview
Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
361 participants
Primary outcome timeframe
Baseline through Week 12
Results posted on
2021-12-14
Participant Flow
Participants were randomized to receive either S5G4T-1 (Encapsulated Benzoyl Peroxide \[E-BPO\] cream) or vehicle in a 2:1 ratio.
Participant milestones
| Measure |
S5G4T-1
Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
|
S5G4T-2 Vehicle Cream
Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
243
|
118
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
239
|
113
|
|
Overall Study
COMPLETED
|
222
|
107
|
|
Overall Study
NOT COMPLETED
|
21
|
11
|
Reasons for withdrawal
| Measure |
S5G4T-1
Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
|
S5G4T-2 Vehicle Cream
Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
9
|
3
|
Baseline Characteristics
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Baseline characteristics by cohort
| Measure |
S5G4T-1
n=243 Participants
Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
|
S5G4T-2 Vehicle Cream
n=118 Participants
Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
|
Total
n=361 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 Years
STANDARD_DEVIATION 13.21 • n=5 Participants
|
52.4 Years
STANDARD_DEVIATION 13.26 • n=7 Participants
|
52.7 Years
STANDARD_DEVIATION 13.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
183 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
86 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
233 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Inflammatory Lesion Count
|
25.7 lesions
STANDARD_DEVIATION 11.07 • n=5 Participants
|
26.3 lesions
STANDARD_DEVIATION 12.45 • n=7 Participants
|
25.9 lesions
STANDARD_DEVIATION 11.52 • n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
0 - Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
1 - Almost Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
2 - Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
3 - Moderate
|
210 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Baseline Investigator's Global Assessment (IGA)
4 - Severe
|
33 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. Multiple imputation (Markov Chain Monte Carlo \[MCMC\]) was used to impute missing values.
Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)".
Outcome measures
| Measure |
S5G4T-1
n=243 Participants
Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
|
S5G4T-2 Vehicle Cream
n=118 Participants
Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12
|
43.5 Percentage of Participants
|
16.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
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.
Outcome measures
| Measure |
S5G4T-1
n=243 Participants
Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
|
S5G4T-2 Vehicle Cream
n=118 Participants
Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Inflammatory Lesion Counts at Week 12
|
-17.4 Inflammatory Lesions
Standard Deviation 9.30
|
-9.5 Inflammatory Lesions
Standard Deviation 9.45
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: The ITT population consisted of all randomized participants who were dispensed study drug. MCMC was used to impute missing values.
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.
Outcome measures
| Measure |
S5G4T-1
n=243 Participants
Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
|
S5G4T-2 Vehicle Cream
n=118 Participants
Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
|
-68.2 Percent Change
Standard Deviation 36.94
|
-38.3 Percent Change
Standard Deviation 37.02
|
Adverse Events
S5G4T-1
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
S5G4T-2 Vehicle Cream
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
S5G4T-1
n=239 participants at risk
Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
|
S5G4T-2 Vehicle Cream
n=113 participants at risk
Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/239 • 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.
|
0.88%
1/113 • 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.
|
Other adverse events
| Measure |
S5G4T-1
n=239 participants at risk
Participants topically applied S5G4T-1 cream, once daily to face for 12 weeks.
|
S5G4T-2 Vehicle Cream
n=113 participants at risk
Participants topically applied S5G4T-2 vehicle cream, once daily to face for 12 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.5%
6/239 • 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.
|
0.88%
1/113 • 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.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
3/239 • 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.
|
1.8%
2/113 • 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.
|
|
General disorders
Application site erythema
|
3.3%
8/239 • 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.
|
1.8%
2/113 • 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.
|
|
General disorders
Application site pain
|
2.1%
5/239 • 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.
|
1.8%
2/113 • 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.
|
|
General disorders
Application site pruritus
|
1.3%
3/239 • 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.
|
0.88%
1/113 • 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.
|
|
General disorders
Application site papules
|
0.00%
0/239 • 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.
|
1.8%
2/113 • 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.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.3%
3/239 • 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.
|
0.00%
0/113 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER