Clinical trial NCT02152800: A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
Official title: A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpes Zoster
Lead sponsor: Yung Shin Pharm. Ind. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Primary Endpoint:

- Lesion assessment - Rash severity, in terms of rash counts

Secondary Endpoints:

* Pain assessment
* Clinical global impression
* Safety information of valacyclovir

Eligibility criteria: 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

Primary outcomes:
measure: the rash severity, in terms of rash counts
timeFrame: Day 28
Secondary outcomes:
measure: VAS Pain score
timeFrame: Day 28
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Zhi-Yuan Shi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: