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

NCT02971891 | Completed Phase 3 Results

• 1 other identifier: CLS006-CO-PR-001
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 30

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)

• 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 Cleared Warts to All 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 (Furosemide)

EXPERIMENTAL

CLS006 (Furosemide) Topical Gel, 0.125%

Drug: CLS006 (Furosemide) Topical Gel

Vehicle

PLACEBO COMPARATOR

Vehicle Topical Gel

Drug: Vehicle Topical Gel

Interventions

CLS006 (Furosemide) Topical Gel DRUG

CLS006 (Furosemide)

Vehicle Topical Gel DRUG

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 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

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.
• 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.

Sponsors & Collaborators

• Maruho Co., Ltd.: lead

Study Sites (30)

Unknown Facility

Mobile, Alabama, 36608, United States

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Glendale, Arizona, 85308, United States

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Los Angeles, California, 90045, United States

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Santa Monica, California, 90404, United States

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Santa Rosa, California, 95403, United States

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Denver, Colorado, 80220, United States

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Miami, Florida, 33137, United States

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North Miami Beach, Florida, 33162, United States

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Ormond Beach, Florida, 32174, United States

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Tampa, Florida, 33624, United States

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Plainfield, Indiana, 46168, United States

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Lake Charles, Louisiana, 70605, United States

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Monroe, Louisiana, 71203, United States

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Hunt Valley, Maryland, 21030, United States

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Beverly, Massachusetts, 01915, United States

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Fort Gratiot, Michigan, 480059, United States

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Omaha, Nebraska, 68144, United States

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Portsmouth, New Hampshire, 03801, United States

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New York, New York, 10022, United States

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High Point, North Carolina, 27262, United States

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Wilmington, North Carolina, 28405, United States

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Fort Washington, Pennsylvania, 19034, United States

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Hazleton, Pennsylvania, 18201, United States

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Austin, Texas, 78759, United States

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College Station, Texas, 77845, United States

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Katy, Texas, 77494, United States

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San Antonio, Texas, 78213, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84117, United States

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Unknown Facility

Lynchburg, Virginia, 24501, United States

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MeSH Terms

Interventions

Furosemide; Gels

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

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: November 21, 2016
• First Posted: November 23, 2016
• Study Start: January 1, 2017
• Primary Completion: April 16, 2018
• Study Completion: July 10, 2018
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-08

Locations

US (30)