To evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections of peginterferon α1b in patients with herpes zoster, and provide support for phase III clinical trials.
This trial is a multicenter, randomized, active drug-controlled, dose-finding phase II clinical study. A total of 5 experimental groups and 1 positive drug control group were set up to evaluate the efficacy, optimal dose and efficacy trend of multiple subcutaneous injections of peginterferon α1b in patients with herpes zoster, and provide support for phase III clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Injecting different doses of the peginterferon α1b into different groups of subjects.
Both valacyclovir tablets and different dose of peginterferon α1b plan to be used in different groups of subjects.
Valacyclovir is a positive control drug.
Chinese Academy of Medical Sciences Dermatology Hospital
Nanjing, Jiangsu, China
Time of stop increasing new blisters/pimples
The number of days it took for the herpes to stop increasing (the original blisters/pimples enlarge, and the blisters/pimples increase) after the subjects were screened and enrolled.
Time frame: 5 days after the first dose
Time of target herpes begins to scab
The time taken for the target herpes (where the herpes first occurred when the patient was enrolled) begin to scab after the subjects were screened for enrollment.
Time frame: 7 days after the first dose.
Time of complete scabbing of all herpes
The time taken for all the herpes to be completely crusted (the blisters have dried up and crusted) after the subjects were screened and enrolled.
Time frame: 10 days after the first dose.
Changes in VAS scores on day 1 from baseline
Changes in VAS scores of subjects on day 1 from baseline.
Time frame: 1 days after the first dose.
Changes in VAS scores on day 2 from baseline
Changes in VAS scores of subjects on day 2 from baseline.
Time frame: 2 days after the first dose.
Changes in VAS scores on day 3 from baseline
Changes in VAS scores of subjects on day 3 from baseline.
Time frame: 3 days after the first dose.
Changes in VAS scores on day 4 from baseline
Changes in VAS scores of subjects on day 4 from baseline.
Time frame: 4 days after the first dose.
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Changes in VAS scores on day 6 from baseline
Changes in VAS scores of subjects on day 6 from baseline.
Time frame: 6 days after the first dose.
Changes in VAS scores on day 10 from baseline
Changes in VAS scores of subjects on day 10 from baseline.
Time frame: 10 days after the first dose.
Changes in VAS scores on day 14 from baseline
Changes in VAS scores of subjects on day 14 from baseline.
Time frame: 14 days after the first dose.
Changes in VAS scores on day 21 from baseline
Changes in VAS scores of subjects on day 21 from baseline.
Time frame: 21 days after the first dose.
Changes in VAS scores on day 27 from baseline
Changes in VAS scores of subjects on day 27 from baseline.
Time frame: 27 days after the first dose.
Time that VAS score to drop to ≤2
The time taken for the VAS score to decrease from baseline ≥3 to ≤2 for the first time after the subjects were screened and enrolled.
Time frame: 10 days after the first dose.
Duration time that VAS score to drop to ≤2
After the subject's VAS score dropped from baseline ≥ 3 to ≤ 2 for the first time, the time that the VAS score remained at ≤ 2.
Time frame: 20 days after the first dose.
The time that scabs of blisters fall off
The number of days it took for the scabs of all herpes to completely fall off after the subjects were screened into the group.
Time frame: 16 days after the first dose.
Dose of painkiller
The dose of painkiller used within 27 days of the subject's first dose.
Time frame: 16 days after the first dose.
Incidence of postherpetic neuralgia
The incidence of hereditary neuralgia within 105 days after the first dose of the subjects. Postherpetic neuralgia is defined as pain lasting one month or more after the rash has healed (ie, complete exfoliation).
Time frame: 105 days after the first dose.