A Phase 3 Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years … (NCT02971891) | Clinical Trial Compass
CompletedPhase 3
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
United States484 participantsStarted 2017-01
Plain-language 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).
Who can participate
Age range2 Years
SexALL
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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…
What they're measuring
1
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.