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)

• Status: Unknown status
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: aRigen Pharmaceuticals, Inc.
• Treatments: Acyclovir; Sorivudine; Valacyclovir

Criteria

Inclusion Criteria:

• at least 18 years of age

• diagnosed with herpes zoster

• confirmed for VZV with lesion swab at screening and subsequent PCR test.

• contraception for women of child-bearing potential

• be able to communicate with investigator and compliant

Exclusion Criteria:

• cytotoxic or immunosuppressive drugs within 3 mos, 5-FU or its pro-drugs, tricyclic antidepressants, probenecid, topical or systemic antiviral drugs or immunomodulatory agents for viral infection

• herpes zoster ophthalmicus

• female patients who are pregnant and/or nursing or planning a pregnancy

• congenital, acquired or corticosteroid-induced immunodeficiency, including malignancy

• renal insufficiency or creatinine level >2mg/dL

• clinical significant liver enzyme abnormalities and any other laboratory abnormalities determined by the screening lab

• history of intolerance or hypersensitivity to the cream components

• current significant skin disease within affected dermatome

• history of positive result for hepatitis B surface antigen, hepatitis C virus, or HIV

• current participation in another clinical drug research study