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This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | CLS001 (Omignan) gel applied once daily |
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| Vehicle Gel | Placebo Comparator | Vehicle gel applied once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLS001 (Omiganan) | Drug | Topical gel |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Absolute Change in Inflammatory Lesion Count | Absolute change in inflammatory lesion count from baseline to Week 12. | 12 weeks |
| Efficacy IGA: 2 Grade Reduction | Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy The Absolute Change in Inflammatory Lesions | The absolute change in inflammatory lesions from baseline to Week 9. | 9 weeks |
| Efficacy The Absolute Change in Inflammatory Lesions | The absolute change in inflammatory lesions from baseline to Week 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Adverse Events | Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Smith | Arkansas | United States | ||||
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The study was conducted at 42 sites in the USA, Canada, Australia/New Zealand, and durope from December 2015 to February 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | CLS001 (Omignan) gel applied once daily CLS001 (Omiganan): Topical gel |
| FG001 | Vehicle Gel | Vehicle gel applied once daily Vehicle: Vehicle 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 | Jul 10, 2015 | Jun 13, 2022 |
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| Drug |
Vehicle gel |
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| 6 weeks |
| Efficacy IGA: 2 Point Reduction | Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | 9 Weeks |
| Efficacy IGA: 2 Point Reduction | Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | 6 Weeks |
| Rogers |
| Arkansas |
| United States |
| Manhattan Beach | California | United States |
| Oceanside | California | United States |
| Washington D.C. | District of Columbia | United States |
| Boynton Beach | Florida | United States |
| Miami | Florida | United States |
| Plainfield | Indiana | United States |
| Watertown | Massachusetts | United States |
| Omaha | Nebraska | United States |
| Verona | New Jersey | United States |
| New York | New York | United States |
| Stony Brook | New York | United States |
| High Point | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Fort Washington | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Arlington | Texas | United States |
| San Antonio | Texas | United States |
| Phillip | Australian Capital Territory | Australia |
| Kogarah | New South Wales | Australia |
| Liverpool | New South Wales | Australia |
| Box Hill | Victoria | Australia |
| Surrey | British Columbia | Canada |
| Courtice | Ontario | Canada |
| Peterborough | Ontario | Canada |
| Windsor | Ontario | Canada |
| Grenoble | France |
| Nantes | France |
| Quimper | France |
| Berlin | Germany |
| Bochum | Germany |
| Bonn | Germany |
| Cologne | Germany |
| Friedrichshafen | Germany |
| Hamburg | Germany |
| Lingen | Germany |
| Mönchengladbach | Germany |
| Osnabrück | Germany |
| Schweinfurt | Germany |
| Nijmegen | Netherlands |
| Auckland | New Zealand |
| Halmstad | Sweden |
| Bradford | England | United Kingdom |
| Birmingham | United Kingdom |
| London | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | CLS001 (Omignan) gel applied once daily CLS001 (Omiganan): Topical gel |
| BG001 | Vehicle Gel | Vehicle gel applied once daily Vehicle: Vehicle gel |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| 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 | Count of Participants | Participants |
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| Total Inflammatory Lesion Count | Defined as the total number of papules and pustules. | Mean | Standard Deviation | lesion count |
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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 | Efficacy Absolute Change in Inflammatory Lesion Count | Absolute change in inflammatory lesion count from baseline to Week 12. | The 'Intent-to-treat' (ITT) analysis population included all randomized subjects. | Posted | Least Squares Mean | Standard Error | Lesions | 12 weeks |
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| Primary | Efficacy IGA: 2 Grade Reduction | Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | The 'Intent-to-treat' (ITT) analysis population included all randomized subjects. | Posted | Number | Percentage of Subjects | 12 weeks |
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| Secondary | Efficacy The Absolute Change in Inflammatory Lesions | The absolute change in inflammatory lesions from baseline to Week 9. | The 'Intent-to-treat' (ITT) analysis population included all randomized subjects. | Posted | Least Squares Mean | Standard Error | Lesions | 9 weeks |
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| Secondary | Efficacy The Absolute Change in Inflammatory Lesions | The absolute change in inflammatory lesions from baseline to Week 6. | The 'Intent-to-treat' (ITT) analysis population included all randomized subjects. | Posted | Least Squares Mean | Standard Error | Lesions | 6 weeks |
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| Secondary | Efficacy IGA: 2 Point Reduction | Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | The 'Intent-to-treat' (ITT) analysis population included all randomized subjects. | Posted | Number | Percentage of Subjects | 9 Weeks |
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| Secondary | Efficacy IGA: 2 Point Reduction | Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | The 'Intent-to-treat' (ITT) analysis population included all randomized subjects. | Posted | Number | Percentage of Subjects | 6 Weeks |
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| Other Pre-specified | Safety Adverse Events | Subjects with 1 or more treatment-related Treatment-Emergent Adverse Events | The 'Intent-to-treat' (ITT) analysis population included all randomized subjects. | Posted | Count of Participants | Participants | 12 weeks |
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|
115 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 | CLS001 (Omignan) gel applied once daily CLS001 (Omiganan): Topical gel | 0 | 136 | 1 | 136 | 47 | 136 |
| EG001 | Vehicle Gel | Vehicle gel applied once daily Vehicle: Vehicle gel | 0 | 127 | 0 | 127 | 36 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Salmonellosis | Infections and infestations | MedDRA Ver. 20 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Ver. 20 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Ver. 20 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Ver. 20 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Ver. 20 | Non-systematic Assessment |
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| 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 pruritus | General disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Rosacea | Skin and subcutaneous tissue disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal 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 | Mar 7, 2017 | 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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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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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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