Psoriasis Clinical Trial

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

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).

View Eligibility Criteria

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 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 is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

491

Study ID:

NCT03259620

Recruitment Status:

Completed

Sponsor:

Maruho Co., Ltd.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 34 Locations for this study

See Locations Near You

Burke Pharmaceutical Research
Hot Springs Arkansas, 71913, United States
Dermatology Specialists, Inc.
Oceanside California, 92056, United States
West Dermatology Research Center
San Diego California, 92121, United States
TCR Medical Corporation
San Diego California, 92123, United States
Colorado Medical Research Center, Inc.
Denver Colorado, 80210, United States
Skin Care Research, Inc.
Boca Raton Florida, 33486, United States
Dermatology Associates & Research
Coral Gables Florida, 33134, United States
International Dermatology Research, Inc.
Miami Florida, 33144, United States
Renstar Medical Research
Ocala Florida, 34471, United States
International Clinical Research - US, LLC
Sanford Florida, 32771, United States
Marietta Dermatology Clinical Research, Inc.
Marietta Georgia, 30060, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis Indiana, 46256, United States
DS Research
New Albany Indiana, 47150, United States
Center for Pharmaceutical Research, LLC
Kansas City Missouri, 64114, United States
MediSearch Clinical Trials
Saint Joseph Missouri, 64506, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor New Jersey, 08520, United States
The Dermatology Group, P.C.
Verona New Jersey, 07044, United States
Academic Dermatology Associates
Albuquerque New Mexico, 87106, United States
Skin Specialty Dermatology
New York New York, 10155, United States
Darst Dermatology
Charlotte North Carolina, 28277, United States
Dermatology Specialists of Charlotte
Charlotte North Carolina, 28277, United States
Wake Research Associates, LLC
Raleigh North Carolina, 27612, United States
Oregon Dermatology And Research Center
Portland Oregon, 97210, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting Pennsylvania, 19462, United States
PEAK Research, LLC
Upper Saint Clair Pennsylvania, 15241, United States
Clinical Research Center of the Carolinas
Charleston South Carolina, 29407, United States
Palmetto Clinical Trial Services, LLC
Fountain Inn South Carolina, 29644, United States
International Clinical Research - Tennessee LLC
Murfreesboro Tennessee, 37130, United States
Tennessee Clinical Research Center
Nashville Tennessee, 37215, United States
Arlington Research Center, Inc.
Arlington Texas, 76011, United States
The University of Texas Health Science Center at Houston
Houston Texas, 77030, United States
Austin Institute for Clinical Research, Inc
Pflugerville Texas, 78660, United States
Dermatology Clinical Research Center of San Antonio
San Antonio Texas, 78229, United States
Virginia Clinical Research, Inc.
Norfolk Virginia, 23502, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

491

Study ID:

NCT03259620

Recruitment Status:

Completed

Sponsor:


Maruho Co., Ltd.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.