Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259620
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Cutaneous Common Warts Drug: CLS006 Drug: CLS006 Vehicle Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 491 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: CLS006
Furosemide Topical Gel, 0.125%
Drug: CLS006
Furosemide Topical Gel

Experimental: CLS006 Vehicle
Vehicle Topical Gel
Drug: CLS006 Vehicle
Vehicle Topical Gel




Primary Outcome Measures :
  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 [ Time Frame: Week 18 ]

Secondary Outcome Measures :
  1. The ratio of cleared warts to all treated warts [ Time Frame: Week 18 ]
  2. Difference in the proportion of subjects with complete clearance of all treated warts at Week 12 [ Time Frame: Week 12 ]
  3. The ratio of cleared warts to all treated warts at Week 12 [ Time Frame: Week 12 ]
  4. Comparisons of reduction from baseline in wart size of treated warts [ Time Frame: Week 18 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259620


Locations
Show Show 35 study locations
Sponsors and Collaborators
Maruho Co., Ltd.
Layout table for additonal information
Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT03259620    
Other Study ID Numbers: CLS006-CO-PR-002
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases