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, 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).

Study Overview

• Status: Completed
• Conditions: Cutaneous Common Warts
• Intervention / Treatment: Drug: CLS006; Drug: CLS006 Vehicle

• Study Type: Interventional
• Enrollment (Actual): 491
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc.
    • San Diego, California, United States, 92123
      • TCR Medical Corporation
    • San Diego, California, United States, 92121
      • West Dermatology Research Center
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center, Inc.
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Inc.
    • Coral Gables, Florida, United States, 33134
      • Dermatology Associates & Research
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Sanford, Florida, United States, 32771
      • International Clinical Research - US, LLC
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Marietta Dermatology Clinical Research, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
    • New Albany, Indiana, United States, 47150
      • DS Research
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center for Pharmaceutical Research, LLC
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
    • Verona, New Jersey, United States, 07044
      • The Dermatology Group, P.C.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • New York, New York, United States, 10155
      • Skin Specialty Dermatology
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Darst Dermatology
    • Charlotte, North Carolina, United States, 28277
      • Dermatology Specialists of Charlotte
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Dermatology Associates of Plymouth Meeting
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • PEAK Research, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas
    • Fountain Inn, South Carolina, United States, 29644
      • Palmetto Clinical Trial Services, LLC
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research - Tennessee LLC
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc.
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research, Inc
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CLS006; Furosemide Topical Gel, 0.125%	Drug: CLS006; Furosemide Topical Gel
Experimental: CLS006 Vehicle; Vehicle Topical Gel	Drug: CLS006 Vehicle; Vehicle Topical Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Week 18

Secondary Outcome Measures

Outcome 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 the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12	Week 12
Change From Baseline in Wart Size for Each Subject	Week 18

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): August 22, 2018
• Study Completion (Actual): November 7, 2018

Study Registration Dates

• First Submitted: August 22, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: CLS006-CO-PR-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No