Clinical trial NCT03259620: A Study to Evaluate the Safety and Efficacy 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: 2017-08-23
Enrollment: 491
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 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
* 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.
* 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.
* 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.

Primary outcomes:
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
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 the Number of Cleared Warts Out of the Number of 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: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Diego
country: United States
facility: West Dermatology Research Center
state: California
city: San Diego
country: United States
facility: TCR Medical Corporation
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc.
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Dermatology Associates & Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Sanford
country: United States
facility: International Clinical Research - US, LLC
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research, Inc.
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: New Albany
country: United States
facility: DS Research
state: Indiana
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research, LLC
state: Missouri
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Verona
country: United States
facility: The Dermatology Group, P.C.
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Skin Specialty Dermatology
state: New York
city: Charlotte
country: United States
facility: Darst Dermatology
state: North Carolina
city: Charlotte
country: United States
facility: Dermatology Specialists of Charlotte
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Portland
country: United States
facility: Oregon Dermatology And Research Center
state: Oregon
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: PEAK Research, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Fountain Inn
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc.
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
References: