Clinical trial NCT02971891: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cutaneous Common Warts
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-23
Enrollment: 484
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Week 18
Secondary outcomes:
measure: The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject
timeFrame: Week 18
measure: Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12.
timeFrame: Week 12
measure: The Ratio of Cleared Warts to All Treated Warts for Each Subject at Week 12
timeFrame: Week 12
measure: Change From Baseline in Wart Size for Each Subject
timeFrame: Week 18
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Plainfield
country: United States
state: Indiana
city: Lake Charles
country: United States
state: Louisiana
city: Monroe
country: United States
state: Louisiana
city: Hunt Valley
country: United States
state: Maryland
city: Beverly
country: United States
state: Massachusetts
city: Fort Gratiot
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Portsmouth
country: United States
state: New Hampshire
city: New York
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Fort Washington
country: United States
state: Pennsylvania
city: Hazleton
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Lynchburg
country: United States
state: Virginia
Study officials:
References: