Cutaneous Common WartsPhase 3NCT02971891
A Phase 3 Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
A Phase 3 study testing CLS006 (Furosemide) Topical Gel in people with Cutaneous Common Warts, run by Maruho Co., Ltd. at 30 sites in United States.
Trial summary
To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital cutaneous common warts (verruca vulgaris). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cutaneous Common Warts
- What is being tested?
- CLS006 (Furosemide) Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 484 participants
- Where
- 30 sitesUnited States
- Study dates
- Jan 2017to 10 Jul 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must have 1 to 6 clearly identifiable common warts located on hands feet limbs, and/or trunk
- Each wart must measure 3 to 10 mm in their longest dimension (diameter) on the epidermal plane of the skin at baseline visit,
- Each wart must be present for at least 4 weeks at the baseline visit,
- Plantar, facial, subungual, and common warts in regions of a pre-existing inflammatory condition are excluded. In addition, other warts (e.g., flat, genital) are excluded.
- Male or female subjects 2 years of age or older
- Females of childbearing potential who are using a highly effective form of birth control or females of non-childbearing potential
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- Negative in-office urine pregnancy test at Screening and Baseline
- Subjects free of any clinically significant dermatologic disorder in the treatment area
- Subjects free of any clinically significant systemic condition which will interfere with the study assessments or increase the risk of AEs
- Subjects willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study
Who cannot join
- Subjects who have used any wart treatments/therapies, prescription or over-the-counter, as follows:
- Salicylic acid, cantharidin, sinecatechins (VeregenTM), simple occlusion (e.g., duct tape), and/or any other over-the-counter wart-removing products in the treatment area within 4 weeks of the Baseline Visit.
- Cryotherapy (e.g., treatment with liquid nitrogen), carbon dioxide, electrodessication, laser, surgery, or other forms of mechanical destruction (e.g., emery boards, clippers, debriders, etc.) in the treatment area within 8 weeks of the Baseline Visit.
- Treatment with immunotherapy (DPCP, DNCB or other), imiquimod, 5-fluorouracil,bleomycin, podophyllin or any other wart immunotherapy or treatment (e.g., Candida antigen) designed to stimulate immune response within 12 weeks of the Baseline Visit.
- Subjects who are immunocompromised.
- Subjects who have taken, within 30 days prior to the Baseline visit, or require treatment with systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) during the course of the study
Show all 13Show fewer
- Subjects who require ongoing treatment with oral or injectable furosemide
- Subjects who have used an investigational drug/device within 30 days of the Baseline visit
- Subjects with known sensitivities to any of the investigational product ingredients including furosemide (or other sulfonamides).
- Subjects who have a clinically significant abnormality of the cardiovascular, hepatic or renal systems.
- Subjects with clinically relevant/significant abnormal laboratory results, vital signs, ECG, and/or physical findings at Screening and/or Baseline
- Subjects with a chronic medical condition or clinically significant abnormal physical or laboratory finding(s) that may require the use of a prohibited medication/treatment.
- Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse within the past year.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Study site
Austin, Texas, 78759
Study site
Beverly, Massachusetts, 01915
Study site
College Station, Texas, 77845
Study site
Denver, Colorado, 80220
Study site
Fort Gratiot, Michigan, 480059
Study site
Fort Washington, Pennsylvania, 19034
Study site
Glendale, Arizona, 85308
Study site
Hazleton, Pennsylvania, 18201
Study site
High Point, North Carolina, 27262
Study site
Hunt Valley, Maryland, 21030
Study site
Katy, Texas, 77494
Study site
Lake Charles, Louisiana, 70605
Study site
Los Angeles, California, 90045
Study site
Lynchburg, Virginia, 24501
Study site
Miami, Florida, 33137
Study site
Mobile, Alabama, 36608
Study site
Monroe, Louisiana, 71203
Study site
New York, New York, 10022
Study site
North Miami Beach, Florida, 33162
Study site
Omaha, Nebraska, 68144
Study site
Ormond Beach, Florida, 32174
Study site
Plainfield, Indiana, 46168
Study site
Portsmouth, New Hampshire, 03801
Study site
Salt Lake City, Utah, 84117
Study site
San Antonio, Texas, 78213
Study site
San Antonio, Texas, 78229
Study site
Santa Monica, California, 90404
Study site
Santa Rosa, California, 95403
Study site
Tampa, Florida, 33624
Study site
Wilmington, North Carolina, 28405
About this study
Official title: A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital cutaneous common warts (verruca vulgaris).
- Conditions
- Cutaneous Common Warts
- Being tested
- CLS006 (Furosemide) Topical Gel, Vehicle Topical Gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLS006 (Furosemide) Topical GelDrug
Vehicle Topical GelDrug
| Study group | Role | What they receive |
|---|---|---|
| CLS006 (Furosemide) | Experimental | CLS006 (Furosemide) Topical Gel, 0.125% Receives: Drug: CLS006 (Furosemide) Topical Gel |
| Vehicle | Placebo comparator | Vehicle Topical Gel Receives: Drug: Vehicle Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation.
Measured: Week 18
Secondary outcomes (4)
The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject
Measured: Week 18
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12.
Measured: Week 12
The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12
Measured: Week 12
Change From Baseline in Wart Size for Each Subject
Measured: Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startJan 2017
- Primary completion16 Apr 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cutaneous Common 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971891
- Sponsor's protocol ID
- CLS006-CO-PR-001
- Status last verified
- Aug 2023
- First submitted
- 21 Nov 2016
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
- ClinicalTrials.gov ID
- NCT02971891
- Acronym / sponsor ID
- CLS006-CO-PR-001
- Conditions
- Cutaneous Common Warts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital cutaneous common warts (verruca vulgaris).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLS006 (Furosemide) | Experimental | Drug: CLS006 (Furosemide) Topical GelCLS006 (Furosemide) Topical Gel, 0.125% |
| Vehicle | Placebo comparator | Drug: Vehicle Topical GelVehicle Topical Gel |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must have 1 to 6 clearly identifiable common warts located on hands feet limbs, and/or trunk
- Male or female subjects 2 years of age or older
- Females of childbearing potential who are using a highly effective form of birth control or females of non-childbearing potential
- Negative in-office urine pregnancy test at Screening and Baseline
- Subjects free of any clinically significant dermatologic disorder in the treatment area
Key exclusion criteria (13 listed)
- Subjects who have used any wart treatments/therapies, prescription or over-the-counter, as follows:
- Subjects who are immunocompromised.
- Subjects who have taken, within 30 days prior to the Baseline visit, or require treatment with systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) during the course of the study
- Subjects who require ongoing treatment with oral or injectable furosemide
- Subjects who have used an investigational drug/device within 30 days of the Baseline visit
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 |
|---|---|---|
| CLS006 (Furosemide) Topical Gel | Drug | CLS006 (Furosemide) |
| Vehicle Topical Gel | Drug | Vehicle |
Primary outcome
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation.
Time frame: Week 18
4 secondary outcomes
The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject
Time frame: Week 18
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12.
Time frame: Week 12
The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12
Time frame: Week 12
Change From Baseline in Wart Size for Each Subject
Time frame: Week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CLS006 (Furosemide) Topical Gel in people with Cutaneous Common Warts, run by Maruho Co., Ltd. at 30 sites in United States.
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 10 inclusion and 13 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation. (time frame: Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2023.