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

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

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.

Study Overview

• Status: Completed
• Conditions: Cutaneous Warts
• Intervention / Treatment: Drug: Furosemide; Drug: Digoxin; Drug: CLS003; Drug: Vehicle topical

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Leiden, Netherlands
    • LUMC/Centre for Human Drug Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLS003; Topical digoxin/furosemide	Drug: CLS003
Experimental: Digoxin topical formulation	Drug: Digoxin
Experimental: Furosemide topical formulation	Drug: Furosemide
Placebo Comparator: Vehicle topical formulation	Drug: Vehicle topical

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.
• Investigators: Principal Investigator: J. (Koos) Burggraaf, MD, PhD, Centre for Human Drug Research

Publications and helpful links

General Publications

• Rijsbergen M, Niemeyer-van der Kolk T, Hogendoorn G, Kouwenhoven S, Lemoine C, Klaassen ES, de Koning M, Beck S, Bouwes Bavinck JN, Feiss G, Burggraaf J, Rissmann R. A randomized controlled proof-of-concept trial of digoxin and furosemide in adults with cutaneous warts. Br J Dermatol. 2019 May;180(5):1058-1068. doi: 10.1111/bjd.17583. Epub 2019 Mar 7.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Estimate): July 28, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Natriuretic Agents; Cardiotonic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Digoxin; Furosemide
• Other Study ID Numbers: CLS003-CO-PR-002