NCT02393417

Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Regimens of CANDIN for Treatment of Common Warts (Verruca Vulgaris)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Nielsen BioSciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a placebo-controlled, double-blind (subject, Investigator, and site staff with the exception of unblinded dedicated staff to handle study medication), phase 2a study with 3 dose cohorts, randomized (concealed) to CANDIN or placebo (3:1). Main study will be up to 20 weeks (10 doses administered every other week) or until a subject has complete resolution of all injectable common warts. Subjects who cannot tolerate dosing every 2 weeks due to a local tolerance issue may be injected at 3-week intervals for up to 10 doses, increasing the length of the study to 29 weeks. Subjects will be followed for 4 months after final injection(s) for evidence of new or reoccurring warts and for safety evaluation.

Conditions

• Warts

Interventions

Type	Name	Description
BIOLOGICAL	CANDIN	Candida albicans Skin Test Antigen for Cellular Hypersensitivity
OTHER	Placebo	0.9% Sodium Chloride Injection USP (non-preserved)

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-01-01
• Completion: 2018-03-01
• First posted: 2015-03-19
• Last updated: 2019-06-04
• Results posted: 2019-06-04

Locations

15 sites across 1 country: United States