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

NCT03259620 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CLS006-CO-PR-002
• Study Type: interventional
• Target: 491
• Locations: 1 country
• Sites: 35

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).

Conditions

Cutaneous Common Warts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

CLS006

EXPERIMENTAL

Furosemide Topical Gel, 0.125%

Drug: CLS006

CLS006 Vehicle

EXPERIMENTAL

Vehicle Topical Gel

Drug: CLS006 Vehicle

Interventions

CLS006 DRUG

Furosemide Topical Gel

CLS006

CLS006 Vehicle DRUG

Vehicle Topical Gel

CLS006 Vehicle

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (35)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Dermatology Specialists, Inc.

Oceanside, California, 92056, United States

Location

West Dermatology Research Center

San Diego, California, 92121, United States

Location

TCR Medical Corporation

San Diego, California, 92123, United States

Location

Colorado Medical Research Center, Inc.

Denver, Colorado, 80210, United States

Location

Skin Care Research, Inc.

Boca Raton, Florida, 33486, United States

Location

Dermatology Associates & Research

Coral Gables, Florida, 33134, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

International Clinical Research - US, LLC

Sanford, Florida, 32771, United States

Location

Marietta Dermatology Clinical Research, Inc.

Marietta, Georgia, 30060, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46256, United States

Location

DS Research

New Albany, Indiana, 47150, United States

Location

Center for Pharmaceutical Research, LLC

Kansas City, Missouri, 64114, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

The Dermatology Group, P.C.

Verona, New Jersey, 07044, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Skin Specialty Dermatology

New York, New York, 10155, United States

Location

Darst Dermatology

Charlotte, North Carolina, 28277, United States

Location

Dermatology Specialists of Charlotte

Charlotte, North Carolina, 28277, United States

Location

Wake Research Associates, LLC

Raleigh, North Carolina, 27612, United States

Location

Oregon Dermatology And Research Center

Portland, Oregon, 97210, United States

Location

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

Location

PEAK Research, LLC

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Palmetto Clinical Trial Services, LLC

Fountain Inn, South Carolina, 29644, United States

Location

International Clinical Research - Tennessee LLC

Murfreesboro, Tennessee, 37130, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Arlington Research Center, Inc.

Arlington, Texas, 76011, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Austin Institute for Clinical Research, Inc

Pflugerville, Texas, 78660, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Results Point of Contact

• Title: Maruho Co.,Ltd. Kyoto R&D Center
• Organization: Clinical Development Dept.

ctinfo@mii.maruho.co.jp

+81-75-325-3255

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 23, 2017
• Study Start: October 30, 2017
• Primary Completion: August 22, 2018
• Study Completion: November 7, 2018
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-08

Locations

US (35)