Psoriasis Clinical Trial
A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
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 â‰¥ 2 years of age with nongenital cutaneous common warts (verruca vulgaris).
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
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.
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There are 34 Locations for this study
Hot Springs Arkansas, 71913, United States
Oceanside California, 92056, United States
San Diego California, 92121, United States
San Diego California, 92123, United States
Denver Colorado, 80210, United States
Boca Raton Florida, 33486, United States
Coral Gables Florida, 33134, United States
Miami Florida, 33144, United States
Ocala Florida, 34471, United States
Sanford Florida, 32771, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60612, United States
Indianapolis Indiana, 46256, United States
New Albany Indiana, 47150, United States
Kansas City Missouri, 64114, United States
Saint Joseph Missouri, 64506, United States
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
Albuquerque New Mexico, 87106, United States
New York New York, 10155, United States
Charlotte North Carolina, 28277, United States
Charlotte North Carolina, 28277, United States
Raleigh North Carolina, 27612, United States
Portland Oregon, 97210, United States
Plymouth Meeting Pennsylvania, 19462, United States
Upper Saint Clair Pennsylvania, 15241, United States
Charleston South Carolina, 29407, United States
Fountain Inn South Carolina, 29644, United States
Murfreesboro Tennessee, 37130, United States
Nashville Tennessee, 37215, United States
Arlington Texas, 76011, United States
Houston Texas, 77030, United States
Pflugerville Texas, 78660, United States
San Antonio Texas, 78229, United States
Norfolk Virginia, 23502, United States
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