A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: S5G4T-1 Participants will topically apply S5G4T-1 cream, once daily to face for 40 weeks. |
Drug: S5G4T-1
Once a day topical cream
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sol-Gel | Rochester | New York | United States | 14623 |
Sponsors and Collaborators
- Sol-Gel Technologies, Ltd.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- SGT-54-07
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | S5G4T-1 |
|---|---|
| Arm/Group Description | Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks. |
| Period Title: Overall Study | |
| STARTED | 547 |
| Received at Least 1 Dose of Study Drug | 535 |
| COMPLETED | 323 |
| NOT COMPLETED | 224 |
Baseline Characteristics
| Arm/Group Title | S5G4T-1 |
|---|---|
| Arm/Group Description | Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks. |
| Overall Participants | 535 |
| Age (Years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [Years] |
51.5
(13.52)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
382
71.4%
|
| Male |
153
28.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
155
29%
|
| Not Hispanic or Latino |
380
71%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
0.2%
|
| Asian |
36
6.7%
|
| Native Hawaiian or Other Pacific Islander |
2
0.4%
|
| Black or African American |
1
0.2%
|
| White |
492
92%
|
| More than one race |
3
0.6%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment. |
| Arm/Group Title | S5G4T-1 |
|---|---|
| Arm/Group Description | Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks. |
| Measure Participants | 535 |
| AEs |
185
34.6%
|
| SAEs |
10
1.9%
|
Adverse Events
| Time Frame | Baseline (Day 0) through end of study (Week 52) | |
|---|---|---|
| Adverse Event Reporting Description | The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment. | |
| Arm/Group Title | S5G4T-1 | |
| Arm/Group Description | Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks. | |
All Cause Mortality |
||
| S5G4T-1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/535 (0%) | |
Serious Adverse Events |
||
| S5G4T-1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/535 (1.9%) | |
| Cardiac disorders | ||
| Arrhythmia | 1/535 (0.2%) | |
| Atrial fibrillation | 1/535 (0.2%) | |
| Injury, poisoning and procedural complications | ||
| Rib fracture | 1/535 (0.2%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Squamous cell carcinoma | 1/535 (0.2%) | |
| Tonsil cancer | 1/535 (0.2%) | |
| Nervous system disorders | ||
| Embolic stroke | 1/535 (0.2%) | |
| Migraine | 1/535 (0.2%) | |
| Renal and urinary disorders | ||
| Nephrolithiasis | 1/535 (0.2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Pulmonary embolism | 1/535 (0.2%) | |
| Surgical and medical procedures | ||
| Mastectomy | 1/535 (0.2%) | |
Other (Not Including Serious) Adverse Events |
||
| S5G4T-1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 98/535 (18.3%) | |
| General disorders | ||
| Application site erythema | 7/535 (1.3%) | |
| Application site pain | 7/535 (1.3%) | |
| Infections and infestations | ||
| Nasopharyngitis | 29/535 (5.4%) | |
| Upper respiratory tract infection | 12/535 (2.2%) | |
| Urinary tract infection | 9/535 (1.7%) | |
| Influenza | 8/535 (1.5%) | |
| Sinusitis | 7/535 (1.3%) | |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 7/535 (1.3%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 6/535 (1.1%) | |
| Vascular disorders | ||
| Hypertension | 6/535 (1.1%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.
Results Point of Contact
| Name/Title | Sol-Gel |
|---|---|
| Organization | Sol-Gel Technologies, Ltd. |
| Phone | 972-8-9313433 |
| info@sol-gel.com |
- SGT-54-07