Clareo Health | A Phase 3 Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Maruho Co., Ltd.
Age
2–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 baseline visit,
* Each wart must be present for at least 4 weeks at the baseline visit,
* Plantar, facial, subungual, and common warts in regions of a pre-existing inflammatory condition are excluded. In addition, other warts (e.g., flat, genital) are 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 be 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.
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 who have a clinically significant abnormality of the cardiovascular, hepatic or renal systems.
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.
