Papulopustular Rosacea
Conditions
Brief summary
To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study SGT-54-02 (NCT03564119).
Detailed description
This is a long-term safety study for participants who completed either study SGT-54-01 or SGT-54-02. Participants will be admitted into the study only after a written informed consent has been obtained and not missing more than 1 visit of Visits 3, 4 or 5 in these studies. Eligible participants for enrollment will apply the study product, S5G4T-1, daily for up to an additional 40 weeks for a total of up to 52 weeks for some participants.
Interventions
DRUGS5G4T-1
Once a day topical cream
Sponsors
Sol-Gel Technologies, Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 the extension study. 2. Participants must complete 12 weeks or within the Week 12 window time (± 4 days) of the double-blind treatment period of Study SGT-54-01 or Study SGT-54-02 and missed not more than 1 visit of Visits 3, 4 or 5 in Study SGT-54-01 or Study SGT-54-02.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 52 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| S5G4T-1 Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks. | 535 |
| Total | 535 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | Other Than Specified | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Study Terminated by Sponsor | 146 |
| Overall Study | Withdrawal by Subject | 48 |
Baseline characteristics
| Characteristic | S5G4T-1 |
|---|---|
| Age, Continuous | 51.5 Years STANDARD_DEVIATION 13.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 155 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 380 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 36 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 492 Participants |
| Sex: Female, Male Female | 382 Participants |
| Sex: Female, Male Male | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 535 |
| other Total, other adverse events | 98 / 535 |
| serious Total, serious adverse events | 10 / 535 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time frame: Baseline up to Week 52
Population: The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S5G4T-1 | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 185 Participants |
| S5G4T-1 | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 10 Participants |