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)
NCT ID: NCT00652184
Last Updated: 2008-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
300 participants
INTERVENTIONAL
2008-03-31
2009-09-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
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
placebo
placebo cream and placebo valaciclovir
valaciclovir
active valaciclovir
2
Placebo cream BID for 10 days and active valaciclovir caplets TID from days 1-10
ARYS-01 (sorivudine) cream 3% or placebo cream
sorivudine cream 3% or placebo cream twice daily for 10 days
placebo
placebo cream and placebo valaciclovir
valaciclovir
active valaciclovir
3
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
ARYS-01 (sorivudine) cream 3% or placebo cream
sorivudine cream 3% or placebo cream twice daily for 10 days
placebo
placebo cream and placebo valaciclovir
valaciclovir
active valaciclovir
4
Active cream BID for 10 days and active valaciclovir caplets TID from days 1-10
ARYS-01 (sorivudine) cream 3% or placebo cream
sorivudine cream 3% or placebo cream twice daily for 10 days
valaciclovir
active valaciclovir
Interventions
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ARYS-01 (sorivudine) cream 3% or placebo cream
sorivudine cream 3% or placebo cream twice daily for 10 days
placebo
placebo cream and placebo valaciclovir
valaciclovir
active valaciclovir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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aRigen Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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aRigen Pharmaceuticals, Inc.
Locations
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ARYS-0701 Site 3
Beverly Hills, California, United States
ARYS-0701 Site 6
Encino, California, United States
ARYS-0701 Site 7
Vista, California, United States
ARYS-0701 Site 8
Henderson, Nevada, United States
ARYS-0701 Site 9
Las Vegas, Nevada, United States
ARYS-0701 Site 10
New York, New York, United States
ARYS-0701 Site 11
New York, New York, United States
ARYS-0701 Site 4
New York, New York, United States
ARYS-0701 Site 12
Raleigh, North Carolina, United States
ARYS-0701 Site 1
Houston, Texas, United States
Countries
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References
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Satyaprakash AK, Tremaine AM, Stelter AA, Creed R, Ravanfar P, Mendoza N, Mehta SK, Rady PL, Pierson DL, Tyring SK. Viremia in acute herpes zoster. J Infect Dis. 2009 Jul 1;200(1):26-32. doi: 10.1086/599381.
Other Identifiers
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ARYS-0701
Identifier Type: -
Identifier Source: org_study_id