A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts

August 21, 2023 updated by: Maruho Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
491

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Week 18
Week 18

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject
Time Frame: Week 18
Week 18
Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12
Time Frame: 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
Time Frame: Week 12
Week 12
Change From Baseline in Wart Size for Each Subject
Time Frame: Week 18
Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maruho Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 7, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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