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

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts

Conditions
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Cutaneous Common Warts

Intervention / Treatment
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* Drug: CLS006
* Drug: CLS006 Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLS006<br>Furosemide Topical Gel, 0.125% | Drug: CLS006<br>* Furosemide Topical Gel<br>|
| Experimental: CLS006 Vehicle<br>Vehicle Topical Gel | Drug: CLS006 Vehicle<br>* Vehicle Topical Gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |