A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of Vacyless® and Valtrex® in patients with acute herpes zoster.

Detailed Description
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Primary Endpoint: - Lesion assessment - Rash severity, in terms of rash counts Secondary Endpoints: Pain assessment Clinical global impression Safety information of valacyclovir

Official Title
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A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster

Conditions
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Herpes Zoster

Intervention / Treatment
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* Drug: valacyclovir hydrocholoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between 20 to 80 years of age. Patients with a clinical diagnosis of HZ as evidenced by a unilateral dermatomal rash. Patients with zoster-related rash (rash severity is greater than or equal to mild). Patients are able to be enrolled into the study 72 hours from appearance of rash (for example, lesions or vesicles). Patients provided written informed consent. Patients who are able to complete all study visits per protocol. Men and premenopausal women must agree to practice a barrier method of birth control or the use of a spermicide for one month after the last dose of study drug (oral contraceptives are not permitted). Subject should be withdrew from the study if contraceptions are faild. Exclusion Criteria: Women who are pregnant or lactating. Patients with multidermatomal or disseminated HZ (greater than 20 lesions beyond the dermatomes adjacent to the primarily involved dermatome). Patients with HZ ophthalmicus, defined as cutaneous lesions in the dermatome associated with the ophthalmic division of the trigeminal nerve Patients with history of impaired renal function, (e.g., calculated creatinine clearance less than 50 mL/min/1.73 m2) Patients are taking narcotic analgesic routinely for a chronic pain condition Patients are taking tricyclic antidepressants Patients who received systemic antivirals with activity against VZV within the past 30 days, or a topical antiviral to treat their current HZ Patients with immunosuppressive or immunodeficient condition resulting from: disease (e.g., HIV) corticosteroid use (except intermittent or topical/inhaled beclomethasone dipropionate or equivalent < 800 mcg/day), or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation ) Patients with any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment) that, in the opinion of the site investigator, might interfere with the evaluations required by the study Patients who are not ambulatory (bed-ridden or homebound); hospitalized patients may be enrolled if they are ambulatory and able to complete the study requirements Patients with history of allergy to valacyclovir hydrochloride and acetaminophen Patients are unlikely to adhere to protocol follow-up

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vacyless® 1000 mg<br>one Vacyless® 1000 mg tablets, 3 times daily for 7days | Drug: valacyclovir hydrocholoride<br> <br> |
| Experimental: Vacyless® 500mg<br>Two Vacyless® 500mg tablets, 3 times daily for 7 days | Drug: valacyclovir hydrocholoride<br> <br> |
| Active Comparator: Valtrex® 500 mg<br>Two Valtrex® 500 mg tablets, 3 times daily for 7days | Drug: valacyclovir hydrocholoride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rash severity, in terms of rash counts |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Pain score |  | Day 28 |