Vial will support Nielsen with their phase 3, randomized, double-blind, placebo-controlled clinical study of CANDIN for the treatment of Verruca vulgaris (common warts) in adolescents and adults in the US and Japan.
Verruca vulgaris are benign lesions caused by infection of the skin with the human papillomavirus (HPV). They are raised lesions on the skin, commonly on the fingers, palms, knees, and soles of the feet. Since warts are caused by a viral infection, skin symptoms can be widespread and refractory.
There is currently no FDA-approved prescription treatment for common warts. CANDIN, a diagnostic skin test, has not yet been approved by the FDA or Japan’s Pharmaceuticals and Medical Devices Agency.
Vial’s Dermatology CRO will work closely with the Nielsen Biosciences team through the completion of the clinical trial.
Wendy Pinson, senior director of clinical operations at Vial, said: “Vial is thrilled to collaborate with Nielsen on their phase 3 clinical trial in the US and Japan.”
“We are committed to delivering high-quality trials powered by innovative technology that are affordable for sponsors. We have full confidence in our ability to drive optimal outcomes for this important study.”
David Burney, COO at Nielsen BioSciences, added: “Common warts are estimated to affect 10% of the global population but have no prescription-approved treatment. We look forward to partnering with the Vial team on CANDIN’s phase 3 clinical trial.”
“Our thoughtful discussion with their team, combined with an outstanding comprehensive presentation, gave us full confidence that this important clinical trial for common warts will be managed to the highest standards in the industry.”
Patient enrolment for the phase 3 clinical trial is expected to start in the second half of 2023.