Cutaneous Common WartsPhase 3NCT03259620
A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
A Phase 3 study testing CLS006 in people with Cutaneous Common Warts, run by Maruho Co., Ltd. at 35 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 491 participants
- Where
- 35 sitesUnited States
- Study dates
- 30 Oct 2017to 7 Nov 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 the baseline visit,
- Each wart must be present for at least 4 weeks at the baseline visit,
- Plantar, facial, subungual, and other warts (e.g., flat, genital) are excluded from treatment (i.e., these wart types are excluded from treatment, however the subject is not 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.
- Female subjects who are pregnant, nursing/breastfeeding, or plan to become pregnant within the study period including the follow-up period.
- Subjects who are immunocompromised.
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- 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
- Subjects with known sensitivities to any of the investigational product ingredients including furosemide (or other sulfonamides).
- 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
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Arlington Research Center, Inc.
Arlington, Texas, 76011
Skin Care Research, Inc.
Boca Raton, Florida, 33486
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407
Darst Dermatology
Charlotte, North Carolina, 28277
Dermatology Specialists of Charlotte
Charlotte, North Carolina, 28277
Rush University Medical Center
Chicago, Illinois, 60612
Dermatology Associates & Research
Coral Gables, Florida, 33134
Colorado Medical Research Center, Inc.
Denver, Colorado, 80210
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Palmetto Clinical Trial Services, LLC
Fountain Inn, South Carolina, 29644
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060
International Dermatology Research, Inc.
Miami, Florida, 33144
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
DS Research
New Albany, Indiana, 47150
Skin Specialty Dermatology
New York, New York, 10155
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Renstar Medical Research
Ocala, Florida, 34471
Dermatology Specialists, Inc.
Oceanside, California, 92056
Austin Institute for Clinical Research, Inc
Pflugerville, Texas, 78660
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
Oregon Dermatology And Research Center
Portland, Oregon, 97210
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
West Dermatology Research Center
San Diego, California, 92121
TCR Medical Corporation
San Diego, California, 92123
International Clinical Research - US, LLC
Sanford, Florida, 32771
PEAK Research, LLC
Upper Saint Clair, Pennsylvania, 15241
The Dermatology Group, P.C.
Verona, New Jersey, 07044
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, CLS006 Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLS006Drug
Furosemide Topical Gel
CLS006 VehicleDrug
Vehicle Topical Gel
| Study group | Role | What they receive |
|---|---|---|
| CLS006 | Experimental | Furosemide Topical Gel, 0.125% Receives: Drug: CLS006 |
| CLS006 Vehicle | Experimental | Vehicle Topical Gel Receives: Drug: CLS006 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 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 the Number of Cleared Warts Out of the Number of 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 Aug 2017
- Study start30 Oct 2017
- Primary completion22 Aug 2018
- Study completion7 Nov 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
- 491 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
- NCT03259620
- Sponsor's protocol ID
- CLS006-CO-PR-002
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2017
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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
- NCT03259620
- Acronym / sponsor ID
- CLS006-CO-PR-002
- Conditions
- Cutaneous Common Warts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 23 Aug 2017 (actual)
- 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 | Experimental | Drug: CLS006Furosemide Topical Gel, 0.125% |
| CLS006 Vehicle | Experimental | Drug: CLS006 VehicleVehicle 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:
- Female subjects who are pregnant, nursing/breastfeeding, or plan to become pregnant within the study period including the follow-up period.
- 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.
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 |
|---|---|---|
| CLS006Furosemide Topical Gel | Drug | CLS006 |
| CLS006 VehicleVehicle Topical Gel | Drug | CLS006 Vehicle |
Primary outcome
The 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 the Number of Cleared Warts Out of the Number of 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.
35 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 in people with Cutaneous Common Warts, run by Maruho Co., Ltd. at 35 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 35 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. 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?
The 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.