Age: ≥ 30 years
# Visits: 12
Diagnosis: Acute Herpes Zoster
# Subjects: 10
Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Val acyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster-Associated Pain.
Coordinator: Maria Perez
Type of Volunteer: Subjects with Acute Herpes Zoster
Length of Study: 120 days
Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash.
Have zoster-related pain as assessed by the ZBPI with a Worst Pain in the last 24 hours Score ≥ 4 :
Are able to be randomized and receive their first dose within 120 hours from appearance of rash ( i.e. Macular/popular or vesicular)
Are willing and able to complete study and procedures, and able to effectively communicate with the investigator and other study personnel.
Subjects with any facial, ophthalmologic, or oral manifestation of AHZ
Subjects with a history of more than 2 prior episodes of diagnosed AHZ
Subjects with residual pain from a prior resolved episode of AHZ with a Worst pain in the last 24 hours score ≥ 1
Subjects who have previously received the zoster vaccine for prophylaxis of AHZ.
Subjects with a creatinine clearance of ˂ 30 mL/min as calculated by the Cockcroft-Gault equation will be excluded and subjects discovered to be ˂ 30 mL/min at Visit 1/Day 1 will discontinue the use of study drug and will be followed through Visit 7/Day 21 for safety.