Back to resultsA Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Primary Purpose
Papulopustular Rosacea
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
S5G4T-1
Sponsored by
About this trial
This is an interventional treatment trial for Papulopustular Rosacea
Eligibility Criteria
Inclusion Criteria:
- Participants must sign an Institutional Review Board (IRB) approved written informed consent for the extension study.
- 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:
-
Sites / Locations
- Sol-Gel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S5G4T-1
Arm Description
Participants will topically apply S5G4T-1 cream, once daily to face for 40 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03564145
First Posted
June 10, 2018
Last Updated
December 13, 2021
Sponsor
Sol-Gel Technologies, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03564145
Brief Title
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Official Title
A Multi-Center, Open-Label, Long-Term Safety Study of S5G4T-1 to Evaluate the Safety of S5G4T-1 in Papulopustular Rosacea Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Per protocol, the Sponsor could terminate the study once 300 participants completed a total of 28 weeks of treatment and 100 participants completed a total of 52 weeks.
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sol-Gel Technologies, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
547 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S5G4T-1
Arm Type
Experimental
Arm Description
Participants will topically apply S5G4T-1 cream, once daily to face for 40 weeks.
Intervention Type
Drug
Intervention Name(s)
S5G4T-1
Other Intervention Name(s)
Encapsulated Benzoyl Peroxide (E-BPO) Cream
Intervention Description
Once a day topical cream
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must sign an Institutional Review Board (IRB) approved written informed consent for the extension study.
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:
-
Facility Information:
Facility Name
Sol-Gel
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
We'll reach out to this number within 24 hrs