Trial Outcomes & Findings for A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea (NCT NCT03564145)
NCT ID: NCT03564145
Last Updated: 2021-12-15
Results Overview
AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. An SAE was defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event. A summary of all SAEs and Other AEs (non-serious) regardless of causality is located in 'Reported Adverse Events' Section.
TERMINATED
PHASE3
547 participants
Baseline up to Week 52
2021-12-15
Participant Flow
Participants who completed either Study SGT-54-01 (NCT03448939) or Study SGT-54-02 (NCT03564119) were assigned to treatment with S5G4T-1 (Encapsulated Benzoyl Peroxide \[E-BPO\] cream).
Participant milestones
| Measure |
S5G4T-1
Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
|
|---|---|
|
Overall Study
STARTED
|
547
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
535
|
|
Overall Study
COMPLETED
|
323
|
|
Overall Study
NOT COMPLETED
|
224
|
Reasons for withdrawal
| Measure |
S5G4T-1
Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lost to Follow-up
|
21
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
48
|
|
Overall Study
Study Terminated by Sponsor
|
146
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Other Than Specified
|
1
|
|
Overall Study
Pregnancy
|
1
|
Baseline Characteristics
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Baseline characteristics by cohort
| Measure |
S5G4T-1
n=535 Participants
Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
|
|---|---|
|
Age, Continuous
|
51.5 Years
STANDARD_DEVIATION 13.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
382 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
380 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
492 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. An SAE was defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event. A summary of all SAEs and Other AEs (non-serious) regardless of causality is located in 'Reported Adverse Events' Section.
Outcome measures
| Measure |
S5G4T-1
n=535 Participants
Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
10 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
185 Participants
|
Adverse Events
S5G4T-1
Serious adverse events
| Measure |
S5G4T-1
n=535 participants at risk
Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Nervous system disorders
Embolic stroke
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Nervous system disorders
Migraine
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Surgical and medical procedures
Mastectomy
|
0.19%
1/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
Other adverse events
| Measure |
S5G4T-1
n=535 participants at risk
Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.4%
29/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
12/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
9/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Infections and infestations
Influenza
|
1.5%
8/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Infections and infestations
Sinusitis
|
1.3%
7/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
7/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
General disorders
Application site erythema
|
1.3%
7/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
General disorders
Application site pain
|
1.3%
7/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
6/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
|
Vascular disorders
Hypertension
|
1.1%
6/535 • Baseline (Day 0) through end of study (Week 52)
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
|
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