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

NCT ID: NCT02971891

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-07-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CLS006 (Furosemide)

CLS006 (Furosemide) Topical Gel, 0.125%

Group Type: EXPERIMENTAL

CLS006 (Furosemide) Topical Gel

Intervention Type: DRUG

Vehicle

Vehicle Topical Gel

Group Type: PLACEBO_COMPARATOR

Vehicle Topical Gel

Intervention Type: DRUG

Interventions

CLS006 (Furosemide) Topical Gel

Intervention Type: DRUG

Vehicle Topical Gel

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maruho Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mobile, Alabama, United States

Glendale, Arizona, United States

Los Angeles, California, United States

Santa Monica, California, United States

Santa Rosa, California, United States

Denver, Colorado, United States

Miami, Florida, United States

North Miami Beach, Florida, United States

Ormond Beach, Florida, United States

Tampa, Florida, United States

Plainfield, Indiana, United States

Lake Charles, Louisiana, United States

Monroe, Louisiana, United States

Hunt Valley, Maryland, United States

Beverly, Massachusetts, United States

Fort Gratiot, Michigan, United States

Omaha, Nebraska, United States

Portsmouth, New Hampshire, United States

New York, New York, United States

High Point, North Carolina, United States

Wilmington, North Carolina, United States

Fort Washington, Pennsylvania, United States

Hazleton, Pennsylvania, United States

Austin, Texas, United States

College Station, Texas, United States

Katy, Texas, United States

San Antonio, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Lynchburg, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLS006-CO-PR-001

Identifier Type: -

Identifier Source: org_study_id