A Phase 2 interventional study of ARYS-01 (sorivudine) cream 3% or placebo cream and placebo in Herpes Zoster and Postherpetic Neuralgia, sponsored by aRigen Pharmaceuticals, Inc.. Status unknown at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-07.
Sponsored by aRigen Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
A multi-center, randomized, 4-arm, placebo-controlled, double-blind efficacy study of ARYS-01 (sorivudine) cream 3%.
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.
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's planned enrollment of 300 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →This is the only study on the registry with aRigen Pharmaceuticals, Inc. as lead sponsor.
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Exclusion Criteria:
Placebo cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10
Drug: placebo · Drug: valaciclovir
Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10
Drug: ARYS-01 (sorivudine) cream 3% or placebo cream · Drug: placebo · Drug: valaciclovir
Active cream BID for 10 days and placebo valaciclovir caplets TID from days 1-3 and active valaciclovir caplets 1 gram TID from days 4-10
Drug: ARYS-01 (sorivudine) cream 3% or placebo cream · Drug: placebo · Drug: valaciclovir
Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10
Drug: ARYS-01 (sorivudine) cream 3% or placebo cream · Drug: valaciclovir
sorivudine cream 3% or placebo cream twice daily for 10 days
Also known as: ARYS-01 cream 3%, sorivudine cream 3%, topical sorivudine 3%
placebo cream and placebo valaciclovir
active valaciclovir
The effect of ARYS-01 (sorivudine) cream (with or without Valaciclovir) on the reduction of the crusting stage of VZV rash present at Day 8.
Time frame: Day 8
The 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.
Time frame: Day 4
This study is status unknown, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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