NCT00652184

Study to Compare Efficacy of Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir and Combination ARYS-01 Cream 3%/Oral Valaciclovir for Treatment of Herpes Zoster (Shingles)

Phase 2/3 Multi-Center, Double-Blind, Controlled Trial Comparing Topical ARYS-01 (Sorivudine) Cream 3%, Oral Valaciclovir, and Combination Topical ARYS-01 Cream /Oral Valaciclovir for Treatment of Herpes Zoster in Immunocompetent Patients 18 Years of Age or Older

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: aRigen Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%.

Detailed description

More than 95% of people are infected with varicella Zoster virus (VZV) at one time of life or another. Primary VZV infection manifests as varicella (chicken pox). The virus then establishes a latent infection of the sensory ganglia from which it may reactivate years later to produce the clinical syndrome of Herpes Zoster (shingles). The initial cutaneous VZV lesions are pruritic, erythematous macules; and the lesions progress through maculopapular stage to vesicular, ulceration and crusting phases. The crusting phase signals the beginning of the healing process, and begins with clouding of the vesicular fluid, within about 24 to 48 h after the appearance of each lesion. This is a Phase 2 study to assess: 1) the overall benefit of ARYS-01 (sorivudine) cream 3% vs. Placebo cream (with immediate or delayed use of Valaciclovir therapy) on Herpes Zoster rash healing rates and postherpetic neuralgia (PHN), 2) the efficacy of ARYS-01 cream 3% vs. Placebo cream, prior to initiation of Valaciclovir, to build evidence for monotherapy treatment benefit of ARYS-01 cream on the initial onset of Herpes Zoster symptoms, 3) the efficacy of ARYS-01 cream 3% vs. Placebo cream, with immediate or delayed initiation of Valaciclovir, for synergetic effects on the initial onset of Herpes Zoster symptoms. The primary efficacy endpoint is the effect of ARYS-01 cream (with or without Valaciclovir) on the reduction of the crusting stage of VZV rash present at Day 8. Secondary endpoints include time to cessation of new lesion formation, and time to cessation of Zoster-associated pains, pain intensity, rash healing and size reduction, and lesion dissemination.

Conditions

• Herpes Zoster
• Postherpetic Neuralgia

Interventions

Type	Name	Description
DRUG	ARYS-01 (sorivudine) cream 3% or placebo cream	sorivudine cream 3% or placebo cream twice daily for 10 days
DRUG	placebo	placebo cream and placebo valaciclovir
DRUG	valaciclovir	active valaciclovir

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-06-01
• Completion: 2009-09-01
• First posted: 2008-04-03
• Last updated: 2008-10-07

Locations

10 sites across 1 country: United States