A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
- Registration Number
- NCT03259620
- Lead Sponsor
- Maruho Co., Ltd.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 491
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Subjects must have 1 to 6 clearly identifiable common warts located on hands, feet, limbs, and/or trunk
- 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).
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Male or female subjects 2 years of age or older
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Females of childbearing potential who are using a highly effective form of birth control or females of non-childbearing potential
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Negative in-office urine pregnancy test at Screening and Baseline
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Subjects free of any clinically significant dermatologic disorder in the treatment area
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Subjects free of any clinically significant systemic condition which will interfere with the study assessments or increase the risk of AEs
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Subjects willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study
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Subjects who have used any wart treatments/therapies, prescription or over-the-counter, as follows:
- 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.
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Female subjects who are pregnant, nursing/breastfeeding, or plan to become pregnant within the study period including the follow-up period.
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Subjects who are immunocompromised.
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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.
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Subjects who require ongoing treatment with oral or injectable furosemide.
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Subjects who have used an investigational drug/device within 30 days of the Baseline visit
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Subjects with known sensitivities to any of the investigational product ingredients including furosemide (or other sulfonamides).
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Subjects with clinically relevant/significant abnormal laboratory results, vital signs, ECG, and/or physical findings at Screening and/or Baseline
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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.
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Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse within the past year.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CLS006 CLS006 Furosemide Topical Gel, 0.125% CLS006 Vehicle CLS006 Vehicle Vehicle Topical Gel
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (35)
Skin Care Research, Inc.
🇺🇸Boca Raton, Florida, United States
International Dermatology Research, Inc.
🇺🇸Miami, Florida, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
West Dermatology Research Center
🇺🇸San Diego, California, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
TCR Medical Corporation
🇺🇸San Diego, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Marietta Dermatology Clinical Research, Inc.
🇺🇸Marietta, Georgia, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Dermatology Specialists, Inc.
🇺🇸Oceanside, California, United States
Colorado Medical Research Center, Inc.
🇺🇸Denver, Colorado, United States
International Clinical Research - US, LLC
🇺🇸Sanford, Florida, United States
Dermatology Associates & Research
🇺🇸Coral Gables, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, 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
The Dermatology Group, P.C.
🇺🇸Verona, New Jersey, United States
Dermatology Specialists of Charlotte
🇺🇸Charlotte, North Carolina, United States
MediSearch Clinical Trials
🇺🇸Saint Joseph, Missouri, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Skin Specialty Dermatology
🇺🇸New York, New York, United States
PEAK Research, LLC
🇺🇸Upper Saint Clair, Pennsylvania, United States
Palmetto Clinical Trial Services, LLC
🇺🇸Fountain Inn, South Carolina, United States
Dermatology Associates of Plymouth Meeting
🇺🇸Plymouth Meeting, Pennsylvania, United States
Clinical Research Center of the Carolinas
🇺🇸Charleston, South Carolina, United States
International Clinical Research - Tennessee LLC
🇺🇸Murfreesboro, Tennessee, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Oregon Dermatology And Research Center
🇺🇸Portland, Oregon, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Darst Dermatology
🇺🇸Charlotte, North Carolina, United States
Arlington Research Center, Inc.
🇺🇸Arlington, Texas, United States
Psoriasis Treatment Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States
Austin Institute for Clinical Research, Inc
🇺🇸Pflugerville, Texas, United States