Topical treatment of verrucae vulgares with Verrumal® in organtransplant recipients (OTR) – prospective, double-blind, placebo-controlled randomised trial - Verrumal in verrucae vulgares (OTRs)

Phase 1

• Conditions: 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.

• Registration Number: EUCTR2005-001593-26-DE
• Lead Sponsor: HERMAL Kurt Herrmann GmbH & Co OHG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-07
• Study Completion: 2007-06-11
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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:
oclinic visits during the prestudy, treatment, and follow-up period
oapplication of study medication (Verrumal® solution, placebo solution)
opre-treatment curettage for virus typing, blood sample and eyebrow hairs
opost-treatment curettage for virus typing
opregnancy 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

·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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified