The goal of this clinical trail is to demonstrate the non-inferiority of recombinant human interferon α-2b gel (ZK-A03) after changing the manufacturer of the active ingredient in patients with herpes zoster. This double-blind study will enroll approximately 368 adult patients with herpes zoster in China. Eligible patients will be assigned randomly at a 1:1 ratio. For each patient who is included, treatment may last up to 10 days. During the study, subjects will be treated with recombinant human interferon α-2b gel (either before or after the alteration of the active ingredient manufacturer), at a frequency of four times a day, together with a background therapy of valaciclovir hydrochloride.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
368
Recombinant human interferon α-2b gel (after the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride.
Recombinant human interferon α-2b gel (before the alteration of the active ingredient manufacturer) will be applied to the lesions as a thin layer, at the frequency of four times a day, together with the therapy of valaciclovir hydrochloride.
Clinical cure rate at visit 4 (Day 7)
Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.
Time frame: 7 Days
Clinical cure rate at visit 3 (Day 4), and visit 5 (Day 11)
Clinical cure is defined as all blisters being dry and crustosus without erosion or ulceration.
Time frame: 11 Days
Time to which new blisters stop appearing
The time from the first day of medication (D1) to the cessation of new blisters.
Time frame: 11 Days
The time to beginning of crusting.
The time from the first day of medication (D1) to the beginning of crusting.
Time frame: 11 Days
The time to which all blisters are crustosus.
The time from the first day of medication (D1) to the crustosus of all blisters.
Time frame: 11 Days
The pain improvement rate at visit 4 (Day 7)
Pain change of ≥1 from baseline is considered as pain improvement.
Time frame: 7 Days
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