ClinicalTrials.gg
CompletedNCT02333643Updated Jul 28, 2016

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

A Phase 2 interventional study of CLS003 and Furosemide in Cutaneous Warts, sponsored by Maruho Co., Ltd.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-28.

Sponsored by Maruho Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cutaneous Warts
03

In context

Lead sponsor

Maruho Co., Ltd. is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
81 participants (actual)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Adverse event to evaluate safety and tolerability of CLS003

    Time frame: Days 0-98

07

Study locations

1 site
  • LUMC/Centre for Human Drug Research
    Leiden, Netherlands
08

References and documents

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. PubMed 30580460 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2014
First posted
Jan 7, 2015
Start
Jan 2015
Primary completionActual
Aug 2015
CompletionActual
Aug 2015
Results delay requested
Jul 25, 2016
Last update
Jul 28, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02333643
Lead sponsor
Maruho Co., Ltd.
Responsible party
Sponsor
First posted
Jan 7, 2015
Start date
Jan 2015
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Jul 28, 2016

Study contacts

J. (Koos) Burggraaf, MD, PhD
principal investigator · Centre for Human Drug Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Furosemide/Digoxin Topical Gel CLS003 · Furosemide · Digoxin

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