A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
NCT ID: NCT03259620
Last Updated: 2023-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
491 participants
INTERVENTIONAL
2017-10-30
2018-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CLS006
Furosemide Topical Gel, 0.125%
CLS006
Furosemide Topical Gel
CLS006 Vehicle
Vehicle Topical Gel
CLS006 Vehicle
Vehicle Topical Gel
Interventions
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CLS006
Furosemide Topical Gel
CLS006 Vehicle
Vehicle Topical Gel
Eligibility Criteria
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Inclusion Criteria
* Each wart must measure 3 to 10 mm in their longest dimension (diameter) on the epidermal plane of the skin at the baseline visit,
* Each wart must be present for at least 4 weeks at the baseline visit,
* Plantar, facial, subungual, and other warts (e.g., flat, genital) are excluded from treatment (i.e., these wart types are excluded from treatment, however the subject is not excluded).
* 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
* Salicylic acid, cantharidin, sinecatechins (VeregenTM), simple occlusion (e.g., duct tape), and/or any other over-the-counter wart-removing products in the treatment area within 4 weeks of the Baseline Visit.
* Cryotherapy (e.g., treatment with liquid nitrogen), carbon dioxide, electrodessication, laser, surgery, or other forms of mechanical destruction (e.g., emery boards, clippers, debriders, etc.) in the treatment area within 8 weeks of the Baseline Visit.
* Treatment with immunotherapy (DPCP, DNCB or other), imiquimod, 5-fluorouracil, bleomycin, podophyllin or any other wart immunotherapy or treatment (e.g., Candida antigen) designed to stimulate immune response within 12 weeks of the Baseline Visit.
* 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.
2 Years
ALL
No
Sponsors
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Maruho Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Dermatology Specialists, Inc.
Oceanside, California, United States
West Dermatology Research Center
San Diego, California, United States
TCR Medical Corporation
San Diego, California, United States
Colorado Medical Research Center, Inc.
Denver, Colorado, United States
Skin Care Research, Inc.
Boca Raton, Florida, United States
Dermatology Associates & Research
Coral Gables, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
International Clinical Research - US, LLC
Sanford, Florida, United States
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
DS Research
New Albany, Indiana, United States
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
The Dermatology Group, P.C.
Verona, New Jersey, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Skin Specialty Dermatology
New York, New York, United States
Darst Dermatology
Charlotte, North Carolina, United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
Oregon Dermatology And Research Center
Portland, Oregon, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, United States
Clinical Research Center of the Carolinas
Charleston, South Carolina, United States
Palmetto Clinical Trial Services, LLC
Fountain Inn, South Carolina, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Austin Institute for Clinical Research, Inc
Pflugerville, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CLS006-CO-PR-002
Identifier Type: -
Identifier Source: org_study_id
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