NCT02333643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

7 months

First QC Date

December 19, 2014

Last Update Submit

July 25, 2016

Conditions

Cutaneous Warts

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (1)

  • Adverse event to evaluate safety and tolerability of CLS003

    Days 0-98

Study Arms (4)

CLS003

EXPERIMENTAL

Topical digoxin/furosemide

Drug: CLS003

Digoxin topical formulation

EXPERIMENTAL
Drug: Digoxin

Furosemide topical formulation

EXPERIMENTAL
Drug: Furosemide

Vehicle topical formulation

PLACEBO COMPARATOR
Drug: Vehicle topical

Interventions

CLS003DRUG
CLS003
FurosemideDRUG
Furosemide topical formulation
DigoxinDRUG
Digoxin topical formulation
Vehicle topicalDRUG
Vehicle topical formulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LUMC/Centre for Human Drug Research

Leiden, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 30580460DERIVED

MeSH Terms

Interventions

FurosemideDigoxin

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur CompoundsDigitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • J. (Koos) Burggraaf, MD, PhD

    Centre for Human Drug Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

January 7, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

NL(1)