Cutaneous WartsPhase 2NCT02333643
A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.
A Phase 2 study testing CLS003, Furosemide and Digoxin in people with Cutaneous Warts, run by Maruho Co., Ltd. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cutaneous Warts
- What is being tested?
- CLS003, Furosemide and Digoxin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2015to Aug 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 10Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cutaneous Warts
- Being tested
- CLS003, Furosemide, Digoxin, Vehicle topical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLS003Drug
FurosemideDrug
DigoxinDrug
Vehicle topicalDrug
| Study group | Role | What they receive |
|---|---|---|
| CLS003 | Experimental | Topical digoxin/furosemide Receives: Drug: CLS003 |
| Digoxin topical formulation | Experimental | Not described Receives: Drug: Digoxin |
| Furosemide topical formulation | Experimental | Not described Receives: Drug: Furosemide |
| Vehicle topical formulation | Placebo comparator | Not described Receives: Drug: Vehicle topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in morphological wart assessment
Measured: Days 14, 28, 42, 70, 98
Change from baseline in Wart size and morphology assessment by standardized clinical photography
Measured: Days 14, 28, 42, 70, 98
Change from baseline in HPV viral load assessment of target lesions by quantitative PCR
Measured: Days 14, 28, 42, 70, 98
Reduction in wart size
Measured: Days 14, 28, 42, 70, 98
Change in the HPV viral load
Measured: Days 14, 28, 42, 70, 98
Change from baseline in mean HPV viral load
Measured: Days 14, 28, 42, 70, 98
Percent clearance of warts
Measured: Days 14, 28, 42, 70, 98
Secondary outcomes (1)
Adverse event to evaluate safety and tolerability of CLS003
Measured: Days 0-98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cutaneous WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. (Koos) Burggraaf, MD, PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333643
- Sponsor's protocol ID
- CLS003-CO-PR-002
- Status last verified
- Jul 2016
- First submitted
- 19 Dec 2014
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02333643
- Acronym / sponsor ID
- CLS003-CO-PR-002
- Conditions
- Cutaneous Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CLS003 | Experimental | Drug: CLS003Topical digoxin/furosemide |
| Digoxin topical formulation | Experimental | Drug: Digoxin |
| Furosemide topical formulation | Experimental | Drug: Furosemide |
| Vehicle topical formulation | Placebo comparator | Drug: Vehicle topical |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLS003 | Drug | CLS003 |
| Furosemide | Drug | Furosemide topical formulation |
| Digoxin | Drug | Digoxin topical formulation |
| Vehicle topical | Drug | Vehicle topical formulation |
Primary outcome
Change from baseline in morphological wart assessment
Time frame: Days 14, 28, 42, 70, 98
Change from baseline in Wart size and morphology assessment by standardized clinical photography
Time frame: Days 14, 28, 42, 70, 98
Change from baseline in HPV viral load assessment of target lesions by quantitative PCR
Time frame: Days 14, 28, 42, 70, 98
Reduction in wart size
Time frame: Days 14, 28, 42, 70, 98
Change in the HPV viral load
Time frame: Days 14, 28, 42, 70, 98
Change from baseline in mean HPV viral load
Time frame: Days 14, 28, 42, 70, 98
Percent clearance of warts
Time frame: Days 14, 28, 42, 70, 98
1 secondary outcome
Adverse event to evaluate safety and tolerability of CLS003
Time frame: Days 0-98
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Derived from this study: PubMed 30580460Rijsbergen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. (Koos) Burggraaf, MD, PhD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CLS003, Furosemide and Digoxin in people with Cutaneous Warts, run by Maruho Co., Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in morphological wart assessment (time frame: Days 14, 28, 42, 70, 98). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02333643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.