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This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Omiganan gel applied once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omiganan | Drug | Topical gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events | Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fremont | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36781451 | Derived | You Y, Liu H, Zhu Y, Zheng H. Rational design of stapled antimicrobial peptides. Amino Acids. 2023 Apr;55(4):421-442. doi: 10.1007/s00726-023-03245-w. Epub 2023 Feb 12. |
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The study was conducted at 28 sites in the USA, Canada, Australia/New Zealand, and Europe from October 2015 to July 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Omiganan gel applied once daily Omiganan: Topical gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 7, 2017 | Jun 13, 2022 |
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| Miami |
| Florida |
| United States |
| Miramar | Florida | United States |
| Tampa | Florida | United States |
| Arlington Heights | Illinois | United States |
| Carmel | Indiana | United States |
| Indianapolis | Indiana | United States |
| Plainfield | Indiana | United States |
| Watertown | Massachusetts | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Pflugerville | Texas | United States |
| Webster | Texas | United States |
| Sydney | New South Wales | Australia |
| Woolloongabba | Queensland | Australia |
| Vancouver | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Drummondville | Quebec | Canada |
| Cannes | France |
| Nice | France |
| Bergen op Zoom | Netherlands |
| Hamilton | New Zealand |
| Wellington | New Zealand |
| Gothenburg | Sweden |
| Lanarkshire | United Kingdom |
| Manchester | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
|
|
The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Omiganan gel applied once daily Omiganan: Topical gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events | Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events | Posted | Number | participants | Up to 12 months |
|
|
|
378 Days
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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 | Treatment | Omiganan gel applied once daily Omiganan: Topical gel | 0 | 307 | 7 | 307 | 83 | 307 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Post concussion syndrome | Injury, poisoning and procedural complications | MedDRA Ver. 20 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Application site pain | General disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Application site erythema | General disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Application site dryness | General disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Ver. 20 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maruho Co.,Ltd. Kyoto R&D Center | Clinical Development Dept. | +81-75-325-3255 | ctinfo@mii.maruho.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 25, 2015 | Jun 13, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000625752 | Omiganan |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Netherlands |
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| United States |
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| United Kingdom |
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| Australia |
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| France |
|