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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02333643
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cutaneous Warts Drug: CLS003 Drug: Furosemide Drug: Digoxin Drug: Vehicle topical Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

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

Primary Outcome Measures :
  1. Change from baseline in morphological wart assessment [ Time Frame: Days 14, 28, 42, 70, 98 ]
  2. Change from baseline in Wart size and morphology assessment by standardized clinical photography [ Time Frame: Days 14, 28, 42, 70, 98 ]
  3. Change from baseline in HPV viral load assessment of target lesions by quantitative PCR [ Time Frame: Days 14, 28, 42, 70, 98 ]
  4. Reduction in wart size [ Time Frame: Days 14, 28, 42, 70, 98 ]
  5. Change in the HPV viral load [ Time Frame: Days 14, 28, 42, 70, 98 ]
  6. Change from baseline in mean HPV viral load [ Time Frame: Days 14, 28, 42, 70, 98 ]
  7. Percent clearance of warts [ Time Frame: Days 14, 28, 42, 70, 98 ]

Secondary Outcome Measures :
  1. Adverse event to evaluate safety and tolerability of CLS003 [ Time Frame: Days 0-98 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02333643

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LUMC/Centre for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Cutanea Life Sciences, Inc.
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Principal Investigator: J. (Koos) Burggraaf, MD, PhD Centre for Human Drug Research

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cutanea Life Sciences, Inc. Identifier: NCT02333643     History of Changes
Other Study ID Numbers: CLS003-CO-PR-002
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Protective Agents