Overview

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