Ano genital warts Infections and Infestations Venereal warts
Conditions
Interventions
Patients are assigned to one of the two arms according to a specially prepared block randomization list of 4 patients. Only after the enrollment of each patient does the statistician communicate to th
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the evaluation includes three options:
1. Com
Sponsors
Isdin (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. First episode never treated 2. Number of lesions: 3 to 10 3. Size of the single lesion: 1-5 mm 4. Location: penis/vulva/perianal region
Exclusion criteria
Exclusion criteria: 1. Previously treated patients 2. Circumcised patients 3. Immunosuppressed patients due to pathological and/or iatrogenic causes 4. Patients with diabetes mellitus 5. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the end of the four sessions and again at three months, the experimenter will evaluate the response to the treatment; the evaluation includes three options: 1. Complete regression 2. Partial regression (reduction = or> 50% of the number of lesions) 3. No regression (<50% reduction in the number of lesions) | — |
Secondary
| Measure | Time frame |
|---|---|
| The tolerability of the two treatments will be assessed by both the investigator and the patient after every treatment session and at the end of the study and will be expressed as good, moderate, poor after evaluation, of 3 parameters: 1. Pain reported by the patient and defined as: mild 1 - moderate 2 - intense 3 2. Itching reported by the patient and defined as: mild 1 - moderate 2 - intense 3 3. Inflammation (observed by the doctor) and defined as: erythema: 1 - erosion: 2 - blisters: 3 - ulcer: 4 | — |
Countries
Italy
Outcome results
None listed