Verrucae vulgares or common warts are benign epithelial tumors of the skin caused by infection with human papilloma viruses (HPV). Due to immunosuppression organ transplant recipients are at high risk for developing viral infections such as HPV-induced warts. The incidence varies from 24-53% depending on the level of their immunosuppressive therapy.
Conditions
Interventions
Trade Name: Verrumal
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: 5-Fluorouracil
CAS Number: 51-21-8
Current Sponsor code: 30003402
Concentration unit: % (W/W) percent weight/weight
Co
Sponsors
HERMAL Kurt Herrmann GmbH & Co OHG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Given written informed consent · Men or women aged 18 or over · Diagnosis of verrucae vulgaris with a minimum duration of 3 months · Organ transplant recipients for a minimum of 2 years · Women are required to use a reliable method of contraception or are postmenopausal · Existence of a minimum of 5 warts – located on hands and forearms · Patient is willing and able to participate in the study as an outpatient, make frequent visits to the clinic, and comply with all study requirements, including the following: o clinic visits during the prestudy, treatment, and follow-up period o application of study medication (Verrumal® solution, placebo solution) o pre-treatment curettage for virus typing, blood sample and eyebrow hairs o post-treatment curettage for virus typing o pregnancy testing for females of childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Known allergic or hypersensitive reactions to components of the study medication · Diagnosis of subungual or periungal warts in the treatment area, · Warts treatment within the previous 3 months before inclusion · Area to be treated exceeds 25 cm² · Patient is taking any medication which could interfere with the study drug and could influence interactions; e.g Methotraxate, Sulfonylurea, Salicylic acid, Dihydropyrimidindehydrogenase-(DPDH)-Inhibitor, Brivudin, systemic 5-FU · Renal failure (creatinine > 6mg/dl) · Serious illness within the previous 4 weeks or life-threatining diseases · Pregnancy or nursing (lactation) · Participation in another clinical trial in the month preceding the study · Patient has a severe illness or psychiatric condition on account of which the patient should not participate in the study in the opinion of the investigator · Patient is suffering from active chemical dependency or alcoholism, as assessed by the investigator. · Maximum of 10 warts in the treatment area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess the response of persistent cutaneous warts to Verrumal® solution in immunosuppressed individuals (OTR). Primary variable is the response to treatment assessed by clinical scoring. ;Secondary Objective: Secondary endpoints will be the evaluation of lesion size; overall improvement / efficacy assessed by investigator and by patient, safety laboratory controls at baseline, week 4 and 8 (creatinine, blood-electrolytes, renal and hepatic values); the evaluation of adverse events and the assessment of local skin reactions at each visit, overall tolerability as rated by investigator and by patient.;Primary end point(s): Primary variable is the response to treatment assessed by clinical scoring | — |
Countries
Germany
Outcome results
None listed