A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.

Study Overview
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Brief Summary
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A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with cutaneous warts.

Official Title
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A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Study to Evaluate Efficacy and Safety of Topical Ionic Contra-viral Therapy (ICVT) Comprised of CLS003 in Cutaneous Warts

Conditions
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Cutaneous Warts

Intervention / Treatment
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* Drug: CLS003
* Drug: Furosemide
* Drug: Digoxin
* Drug: Vehicle topical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: absence of evidence of any active or chronic disease; Free of clinical significant systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events; Have at least 2 (non-subungual) common warts or at least 2 plantar warts on non-genital, nonfacial skin Exclusion Criteria: Any clinically significant abnormality that in the opinion of the investigator would interfere with the study objectives or compromise subject safety; For women: a positive pregnancy test and/or nursing at screening or women who plan to become pregnant or are breastfeeding; A positive test for drugs of abuse at screening; History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 28 units/week); Positive test results for Hepatitis B, Hepatitis C or HIV; Have used salicylic acid or any other over-the-counter wart-removing product in the treatment area within 30 days prior to starting the study or cryotherapy within 60 days of starting the study; Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrollment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed; Have a known sensitivity to any of the investigational product ingredients Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening; Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLS003<br>Topical digoxin/furosemide | Drug: CLS003<br> <br> |
| Experimental: Digoxin topical formulation<br> | Drug: Digoxin<br> <br> |
| Experimental: Furosemide topical formulation<br> | Drug: Furosemide<br> <br> |
| Placebo Comparator: Vehicle topical formulation<br> | Drug: Vehicle topical<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in morphological wart assessment |  | Days 14, 28, 42, 70, 98 | 
| Change from baseline in Wart size and morphology assessment by standardized clinical photography |  | Days 14, 28, 42, 70, 98 | 
| Change from baseline in HPV viral load assessment of target lesions by quantitative PCR |  | Days 14, 28, 42, 70, 98 | 
| Reduction in wart size |  | Days 14, 28, 42, 70, 98 | 
| Change in the HPV viral load |  | Days 14, 28, 42, 70, 98 | 
| Change from baseline in mean HPV viral load |  | Days 14, 28, 42, 70, 98 | 
| Percent clearance of warts |  | Days 14, 28, 42, 70, 98 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event to evaluate safety and tolerability of CLS003 |  | Days 0-98 |