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

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 (Furosemide) Topical Gel; Drug: Vehicle Topical Gel

• Study Type: Interventional
• Enrollment (Actual): 484
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
  • Arizona
    • Glendale, Arizona, United States, 85308
  • California
    • Los Angeles, California, United States, 90045
    • Santa Monica, California, United States, 90404
    • Santa Rosa, California, United States, 95403
  • Colorado
    • Denver, Colorado, United States, 80220
  • Florida
    • Miami, Florida, United States, 33137
    • North Miami Beach, Florida, United States, 33162
    • Ormond Beach, Florida, United States, 32174
    • Tampa, Florida, United States, 33624
  • Indiana
    • Plainfield, Indiana, United States, 46168
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
    • Monroe, Louisiana, United States, 71203
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
  • Michigan
    • Fort Gratiot, Michigan, United States, 480059
  • Nebraska
    • Omaha, Nebraska, United States, 68144
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
  • New York
    • New York, New York, United States, 10022
  • North Carolina
    • High Point, North Carolina, United States, 27262
    • Wilmington, North Carolina, United States, 28405
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
    • Hazleton, Pennsylvania, United States, 18201
  • Texas
    • Austin, Texas, United States, 78759
    • College Station, Texas, United States, 77845
    • Katy, Texas, United States, 77494
    • San Antonio, Texas, United States, 78229
    • San Antonio, Texas, United States, 78213
  • Utah
    • Salt Lake City, Utah, United States, 84117
  • Virginia
    • Lynchburg, Virginia, United States, 24501

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 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.

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); CLS006 (Furosemide) Topical Gel, 0.125%	Drug: CLS006 (Furosemide) Topical Gel
Placebo Comparator: Vehicle; Vehicle Topical Gel	Drug: Vehicle Topical Gel

What is the study measuring?

Primary Outcome Measures

Outcome 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 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
Change From Baseline in Wart Size 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

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): April 16, 2018
• Study Completion (Actual): July 10, 2018

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimated): November 23, 2016

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; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: CLS006-CO-PR-001