A Study to Evaluate the Safety and Efficacy of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 2 - Any |
Updated: | 11/22/2018 |
Start Date: | October 30, 2017 |
End Date: | November 7, 2018 |
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
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).
Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital
cutaneous common warts (verruca vulgaris).
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.
We found this trial at
35
sites
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59 One Mile Road
East Windsor, New Jersey 08520
East Windsor, New Jersey 08520
609-443-4500
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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7810 Louis Pasteur
San Antonio, Texas 78229
San Antonio, Texas 78229
210-692-1382
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8936 Blakeney Professional Drive
Charlotte, North Carolina 28277
Charlotte, North Carolina 28277
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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