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

Cutaneous Common Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03259620
• Other study ID #: CLS006-CO-PR-002
• Status: Completed
• Phase: Phase 3
• Start date: October 30, 2017
• Est. completion date: November 7, 2018

Study information

• Verified date: August 2023
• Source: Maruho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: November 7, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Common Warts
• Warts

Intervention

Drug:
• CLS006
Furosemide Topical Gel
• CLS006 Vehicle
Vehicle Topical Gel

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Arlington Research Center, Inc.	Arlington	Texas
United States	Skin Care Research, Inc.	Boca Raton	Florida
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	Darst Dermatology	Charlotte	North Carolina
United States	Dermatology Specialists of Charlotte	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Dermatology Associates & Research	Coral Gables	Florida
United States	Colorado Medical Research Center, Inc.	Denver	Colorado
United States	Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	Palmetto Clinical Trial Services, LLC	Fountain Inn	South Carolina
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	Center for Pharmaceutical Research, LLC	Kansas City	Missouri
United States	Marietta Dermatology Clinical Research, Inc.	Marietta	Georgia
United States	International Dermatology Research, Inc.	Miami	Florida
United States	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	DS Research	New Albany	Indiana
United States	Skin Specialty Dermatology	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Austin Institute for Clinical Research, Inc	Pflugerville	Texas
United States	Dermatology Associates of Plymouth Meeting	Plymouth Meeting	Pennsylvania
United States	Oregon Dermatology And Research Center	Portland	Oregon
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas
United States	TCR Medical Corporation	San Diego	California
United States	West Dermatology Research Center	San Diego	California
United States	International Clinical Research - US, LLC	Sanford	Florida
United States	PEAK Research, LLC	Upper Saint Clair	Pennsylvania
United States	The Dermatology Group, P.C.	Verona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Maruho Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject		Week 18
Secondary	Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12		Week 12
Secondary	The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12		Week 12
Secondary	Change From Baseline in Wart Size for Each Subject		Week 18