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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 (Omiganan) 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 |
|---|---|---|
| Change in Inflammatory Lesion Count From Baseline to Week 12 | Change from Baseline to Week 12 in Inflammatory Lesion Count | 12 weeks |
| Percentage of Participants Who Achieved 2 Grade IGA Reduction. | Percentage of participants 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 |
|---|---|---|
| Change in the Number of Inflammatory Lesions From Baseline at Week 9 | The absolute change in inflammatory lesions from baseline to Week 9 | 9 weeks |
| Change in the Number of Inflammatory Lesions From Baseline at Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fremont | California | United States | ||||
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The study was conducted at 42 sites in the USA, Canada, Australia/New Zealand, and Europe from December 2015 to July 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | CLS001 (Omiganan) Gel | CLS001 (Omiganan) gel applied once daily CLS001 (Omiganan): Topical gel |
| FG001 | Vehicle Gel | Vehicle gel applied once daily Vehicle: Vehicle Gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Study Period |
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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 31, 2017 | Jun 13, 2022 |
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| Drug |
Vehicle Gel |
|
The absolute change in inflammatory lesions from baseline to Week 6
| 6 weeks |
| Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9. | Percentage of participants 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 |
| Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6. | Percentage of participants 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 |
| Miami |
| Florida |
| United States |
| Miramar | Florida | United States |
| Tampa | Florida | United States |
| Arlington Heights | Illinois | United States |
| Carmel | Indiana | United States |
| Fort Gratiot | Michigan | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | United States |
| Stony Brook | New York | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Charlottesville | Virginia | United States |
| Woolloongabba | Queensland | Australia |
| Carlton | Victoria | Australia |
| East Melbourne | Victoria | Australia |
| Hamilton | Ontario | Canada |
| Toronto | Ontario | Canada |
| Brest | France |
| Nancy | France |
| Nice | France |
| Rouen | France |
| Thionville | France |
| Augsburg | Germany |
| Berlin | Germany |
| Bochum | Germany |
| Darmstadt | Germany |
| Dresden | Germany |
| Dülmen | Germany |
| Frankfurt | Germany |
| Ibbenbueren | Germany |
| Lübeck | Germany |
| Mahlow | Germany |
| Münster | Germany |
| Rotterdam | Netherlands |
| Hamilton | New Zealand |
| Gothenburg | Sweden |
| Lanarkshire | United Kingdom |
| Leeds | United Kingdom |
| Manchester | United Kingdom |
| Surrey | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| Open-Label Study Period |
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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 (Omiganan) 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 |
| ||||||||||||||||||
| 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 | Number | participants |
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| Fitzpatrick Skin Type | Count of Participants | 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 | Change in Inflammatory Lesion Count From Baseline to Week 12 | Change from Baseline to Week 12 in Inflammatory Lesion Count | 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 | Percentage of Participants Who Achieved 2 Grade IGA Reduction. | Percentage of participants 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 Participants | 12 weeks |
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| Secondary | Change in the Number of Inflammatory Lesions From Baseline at Week 9 | 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 | Change in the Number of Inflammatory Lesions From Baseline at Week 6 | 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 | Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9. | Percentage of participants who achieved 2 grade IGA reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | Posted | Number | Percentage of Participants | 9 Weeks |
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| Secondary | Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6. | Percentage of participants 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 Participants | 6 Weeks |
|
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12-week in Double-Blind Period and maximum 1 year in Open-Label Period
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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 | CLS001 (Omiganan) Gel (Double-Blind Period) | CLS001 (Omiganan) topical gel applied once daily for 12-week | 0 | 235 | 4 | 235 | 83 | 235 |
| EG001 | Vehicle Gel (Double-Blind Period) | Vehicle topical gel applied once daily for 12-week | 0 | 228 | 4 | 228 | 83 | 228 |
| EG002 | CLS001 (Omiganan) Gel (Open-Label Period) | CLS001 (Omiganan) topical gel applied once daily for maximum 1-year | 0 | 363 | 8 | 363 | 116 | 363 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Seizures | Nervous system disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 20 | Non-systematic Assessment |
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| Achilles tendon rupture left | Injury, poisoning and procedural complications | MedDRA Ver. 20 | Non-systematic Assessment |
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| B-cell non hodgkin lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 20 | Non-systematic Assessment |
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| Acute cellulitis | Infections and infestations | MedDRA Ver. 20 | Non-systematic Assessment |
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| Melanoma in situ of the lentigo maligna type, level 1 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 20 | Non-systematic Assessment |
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| Herniated vertebral disc (cervical spine) | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Primary gonarthrosis left | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Renal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 dermatitis | General disorders | 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 pruritus | 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 |
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| Headache | Nervous system disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Ver. 20 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 20 | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue 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 | Jun 29, 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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| Lost to Follow-up |
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| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Terminated by Sponsor |
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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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| Canada |
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| Netherlands |
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| Sweden |
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| United States |
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| United Kingdom |
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| Australia |
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| France |
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| Germany |
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| II - Usually burn, tans less than average (with difficulty) |
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| III - Sometimes mild burn, tans less than average |
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| IV - Rarely burn, tan more than average (with ease) |
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| V - Rarely burns, tans profusely |
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| VI - Never burns, tans profusely |
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