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

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).

Timeline

Start

2017-01

Primary completion

2018-04-16

Completion

2018-07-10

Outcome

Missed primary endpoint

registry COUNT_OF_PARTICIPANTS CLS006 (Furosemide): Achieved complete clearance of all treated warts: 32 Participants NCT02971891 ↗

registry analysis (superiority test); CLS006 (Furosemide); p = 0.1789; Cochran-Mantel-Haenszel NCT02971891 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Furosemide	Other / unclassified	0.125 %	Topical

Indications