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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.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S5G4T-1 | Experimental | Participants will topically apply S5G4T-1 cream, once daily to face for 40 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S5G4T-1 | Drug | Once a day topical cream |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sol-Gel | Rochester | New York | 14623 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37636251 | Derived | Werschler WP, Sugarman J, Bhatia N, Baldwin H, Green LJ, Nov O, Ram V, Levy-Hacham O, Stein Gold L. Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials. J Clin Aesthet Dermatol. 2023 Aug;16(8):27-33. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | S5G4T-1 | Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | S5G4T-1 | Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The safety population included all participants who received at least 1 confirmed dose of S5G4T-1 and had at least 1 assessment. | Posted | Count of Participants | Participants | Baseline up to Week 52 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | S5G4T-1 | Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sol-Gel | Sol-Gel Technologies, Ltd. | 972-8-9313433 | info@sol-gel.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2018 | Dec 13, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2019 | Nov 9, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Withdrawal by Subject |
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| Study Terminated by Sponsor |
|
| Physician Decision |
|
| Other Than Specified |
|
| Pregnancy |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| S5G4T-1 |
Participants topically applied S5G4T-1 cream, once daily to face for 40 weeks. |
|
|
| 0 |
| 535 |
| 10 |
| 535 |
| 98 |
| 535 |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
|
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Non-systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Mastectomy | Surgical and medical procedures | MedDRA 21.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
Generally, the Principal Investigator is not permitted to discuss or publish trial results without Sponsor approval.