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To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital cutaneous common warts (verruca vulgaris).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLS006 | Experimental | Furosemide Topical Gel, 0.125% |
|
| CLS006 Vehicle | Experimental | Vehicle Topical Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLS006 | Drug | Furosemide Topical Gel |
| |
| CLS006 Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation | Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject | Week 18 | |
| Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12 | Week 12 |
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Inclusion Criteria:
Subjects must have 1 to 6 clearly identifiable common warts located on hands, feet, limbs, and/or trunk
Male or female subjects 2 years of age or older
Females of childbearing potential who are using a highly effective form of birth control or females of non-childbearing potential
Negative in-office urine pregnancy test at Screening and Baseline
Subjects free of any clinically significant dermatologic disorder in the treatment area
Subjects free of any clinically significant systemic condition which will interfere with the study assessments or increase the risk of AEs
Subjects willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study
Exclusion Criteria:
Subjects who have used any wart treatments/therapies, prescription or over-the-counter, as follows:
Female subjects who are pregnant, nursing/breastfeeding, or plan to become pregnant within the study period including the follow-up period.
Subjects who are immunocompromised.
Subjects who have taken, within 30 days prior to the Baseline visit, or require treatment with systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) during the course of the study.
Subjects who require ongoing treatment with oral or injectable furosemide.
Subjects who have used an investigational drug/device within 30 days of the Baseline visit
Subjects with known sensitivities to any of the investigational product ingredients including furosemide (or other sulfonamides).
Subjects with clinically relevant/significant abnormal laboratory results, vital signs, ECG, and/or physical findings at Screening and/or Baseline
Subjects with a chronic medical condition or clinically significant abnormal physical or laboratory finding(s) that may require the use of a prohibited medication/treatment.
Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse within the past year.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States | ||
| Dermatology Specialists, Inc. |
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Subjects must have 1 to 6 clearly identifiable common warts located on hands, feet, limbs, and/or trunk
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| ID | Title | Description |
|---|---|---|
| FG000 | CLS006 | Furosemide Topical Gel applied once daily Furosemide Topical Gel, 0.125% |
| FG001 | CLS006 Vehicle | Vehicle Topical Gel applied once daily Vehicle 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 | May 23, 2017 | May 18, 2023 |
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| Drug |
Vehicle Topical Gel |
|
| The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12 | Week 12 |
| Change From Baseline in Wart Size for Each Subject | Week 18 |
| Oceanside |
| California |
| 92056 |
| United States |
| West Dermatology Research Center | San Diego | California | 92121 | United States |
| TCR Medical Corporation | San Diego | California | 92123 | United States |
| Colorado Medical Research Center, Inc. | Denver | Colorado | 80210 | United States |
| Skin Care Research, Inc. | Boca Raton | Florida | 33486 | United States |
| Dermatology Associates & Research | Coral Gables | Florida | 33134 | United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| International Clinical Research - US, LLC | Sanford | Florida | 32771 | United States |
| Marietta Dermatology Clinical Research, Inc. | Marietta | Georgia | 30060 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| DS Research | New Albany | Indiana | 47150 | United States |
| Center for Pharmaceutical Research, LLC | Kansas City | Missouri | 64114 | United States |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| The Dermatology Group, P.C. | Verona | New Jersey | 07044 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Skin Specialty Dermatology | New York | New York | 10155 | United States |
| Darst Dermatology | Charlotte | North Carolina | 28277 | United States |
| Dermatology Specialists of Charlotte | Charlotte | North Carolina | 28277 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Oregon Dermatology And Research Center | Portland | Oregon | 97210 | United States |
| Dermatology Associates of Plymouth Meeting | Plymouth Meeting | Pennsylvania | 19462 | United States |
| PEAK Research, LLC | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Clinical Research Center of the Carolinas | Charleston | South Carolina | 29407 | United States |
| Palmetto Clinical Trial Services, LLC | Fountain Inn | South Carolina | 29644 | United States |
| International Clinical Research - Tennessee LLC | Murfreesboro | Tennessee | 37130 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| Arlington Research Center, Inc. | Arlington | Texas | 76011 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Austin Institute for Clinical Research, Inc | Pflugerville | Texas | 78660 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Subjects Who Had 1 Wart |
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| Subjects Who Had 2 Warts |
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| Subjects Who Had 3 Warts |
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| Subjects Who Had 4 Warts |
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| Subjects Who Had 5 Warts |
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| Subjects Who Had 6 Warts |
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| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CLS006 | Furosemide Topical Gel, 0.125% |
| BG001 | CLS006 Vehicle | Vehicle Topical Gel |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation | Posted | Count of Participants | Participants | Week 18 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject | Posted | Mean | Standard Deviation | Ratio of Cleared Warts | Week 18 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12 | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12 | Posted | Mean | Standard Deviation | ratio of cleared warts | Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Wart Size for Each Subject | Posted | Mean | Standard Deviation | mm | Week 18 |
|
|
18 weeks
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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 | CLS006 | Furosemide Topical Gel, 0.125% | 1 | 245 | 3 | 245 | 23 | 245 |
| EG001 | CLS006 Vehicle | Vehicle Topical Gel | 1 | 246 | 3 | 246 | 14 | 246 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cardiomyopathy | Cardiac disorders | Systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Bacterial colitis | Infections and infestations | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Multiple sclerosis | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | 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 | Oct 25, 2017 | May 18, 2023 | SAP_001.pdf |
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| >=12 to <18 |
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| >=18 to <65 |
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| >=65 |
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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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