A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts

Completed · Phase 3

Conditions studied: Cutaneous Common Warts

In brief

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).

Key facts

Study ID

NCT03259620

Run by

Maruho Co., Ltd.

People needed

491

Starts

2017-10-30

Expected to finish

2018-11-07

Last updated by the study team

2023-09-14

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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

You may not qualify if…

• 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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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