Back to resultsA Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.
Primary Purpose
Cutaneous Warts
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
CLS003
Furosemide
Digoxin
Vehicle topical
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Warts
Eligibility Criteria
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;
Sites / Locations
- LUMC/Centre for Human Drug Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
CLS003
Digoxin topical formulation
Furosemide topical formulation
Vehicle topical formulation
Arm Description
Topical digoxin/furosemide
Outcomes
Primary Outcome Measures
Change from baseline in morphological wart assessment
Change from baseline in Wart size and morphology assessment by standardized clinical photography
Change from baseline in HPV viral load assessment of target lesions by quantitative PCR
Reduction in wart size
Change in the HPV viral load
Change from baseline in mean HPV viral load
Percent clearance of warts
Secondary Outcome Measures
Adverse event to evaluate safety and tolerability of CLS003
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02333643
Brief Title
A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Warts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLS003
Arm Type
Experimental
Arm Description
Topical digoxin/furosemide
Arm Title
Digoxin topical formulation
Arm Type
Experimental
Arm Title
Furosemide topical formulation
Arm Type
Experimental
Arm Title
Vehicle topical formulation
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CLS003
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Type
Drug
Intervention Name(s)
Vehicle topical
Primary Outcome Measure Information:
Title
Change from baseline in morphological wart assessment
Time Frame
Days 14, 28, 42, 70, 98
Title
Change from baseline in Wart size and morphology assessment by standardized clinical photography
Time Frame
Days 14, 28, 42, 70, 98
Title
Change from baseline in HPV viral load assessment of target lesions by quantitative PCR
Time Frame
Days 14, 28, 42, 70, 98
Title
Reduction in wart size
Time Frame
Days 14, 28, 42, 70, 98
Title
Change in the HPV viral load
Time Frame
Days 14, 28, 42, 70, 98
Title
Change from baseline in mean HPV viral load
Time Frame
Days 14, 28, 42, 70, 98
Title
Percent clearance of warts
Time Frame
Days 14, 28, 42, 70, 98
Secondary Outcome Measure Information:
Title
Adverse event to evaluate safety and tolerability of CLS003
Time Frame
Days 0-98
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. (Koos) Burggraaf, MD, PhD
Organizational Affiliation
Centre for Human Drug Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
LUMC/Centre for Human Drug Research
City
Leiden
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
30580460
Citation
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.
Results Reference
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A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.
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