Cutaneous Common Warts
Conditions
Brief 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).
Interventions
DRUGCLS006 (Furosemide) Topical Gel
Sponsors
Maruho Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Week 18 |
Secondary
| Measure | Time frame |
|---|---|
| The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject | Week 18 |
| Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | Week 12 |
| The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12 | Week 12 |
| Change From Baseline in Wart Size for Each Subject | Week 18 |
Countries
United States
Participant flow
Recruitment details
Subjects must have 1 to 6 clearly identifiable common warts located on hands, feet, limbs, and/or trunk
Participants by arm
| Arm | Count |
|---|---|
| CLS006 (Furosemide) CLS006 (Furosemide) Topical Gel, 0.125% | 246 |
| Vehicle Vehicle Topical Gel | 238 |
| Total | 484 |
Baseline characteristics
| Characteristic | CLS006 (Furosemide) | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 28.6 years STANDARD_DEVIATION 16.4 | 29.1 years STANDARD_DEVIATION 16.57 | 28.8 years STANDARD_DEVIATION 16.47 |
| Age, Customized >=12 to <18 | 41 Participants | 43 Participants | 84 Participants |
| Age, Customized >=18 to <65 | 158 Participants | 154 Participants | 312 Participants |
| Age, Customized >=2 to <12 | 43 Participants | 37 Participants | 80 Participants |
| Age, Customized >=65 | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 39 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 205 Participants | 199 Participants | 404 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 10 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) White | 226 Participants | 221 Participants | 447 Participants |
| Sex: Female, Male Female | 105 Participants | 101 Participants | 206 Participants |
| Sex: Female, Male Male | 141 Participants | 137 Participants | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 246 | 0 / 238 |
| other Total, other adverse events | 9 / 246 | 9 / 238 |
| serious Total, serious adverse events | 0 / 246 | 0 / 238 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CLS006 (Furosemide) | 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. | Achieved complete clearance of all treated warts | 32 Participants |
| CLS006 (Furosemide) | 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. | Not achieved complete clearance of all treated warts | 197 Participants |
| Vehicle | 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. | Not achieved complete clearance of all treated warts | 190 Participants |
| Vehicle | 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. | Achieved complete clearance of all treated warts | 24 Participants |
p-value: 0.1789Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Wart Size for Each Subject
Time frame: Week 18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS006 (Furosemide) | Change From Baseline in Wart Size for Each Subject | -2.5 mm | Standard Deviation 7.13 |
| Vehicle | Change From Baseline in Wart Size for Each Subject | -2.4 mm | Standard Deviation 6.64 |
Secondary
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12.
Time frame: Week 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CLS006 (Furosemide) | Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | Complete clearance of all treated warts | 21 Participants |
| CLS006 (Furosemide) | Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | Not complete clearance of all treated warts | 208 Participants |
| Vehicle | Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | Complete clearance of all treated warts | 14 Participants |
| Vehicle | Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12. | Not complete clearance of all treated warts | 200 Participants |
Secondary
The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12
Time frame: Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS006 (Furosemide) | The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12 | 0.120 ratio of cleared warts | Standard Deviation 0.3041 |
| Vehicle | The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12 | 0.087 ratio of cleared warts | Standard Deviation 0.2601 |
Secondary
The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject
Time frame: Week 18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLS006 (Furosemide) | The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject | 0.178 ratio of cleared warts | Standard Deviation 0.3636 |
| Vehicle | The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject | 0.145 ratio of cleared warts | Standard Deviation 0.3334 |