Clinical trial to investigate clinical efficacy and tolerability of Verrumal in actinic keratosis (PoC) - Verrumal in AK

• Conditions: actinic keratosis; MedDRA version: 8.1Level: LLTClassification code 10000614Term: Actinic keratosis

• Registration Number: EUCTR2006-005432-24-DE
• Lead Sponsor: Hermal Kurt Herrmann GmbH & Co OHG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

·All of the following criteria have to be met for inclusion of a subject in the study:
•male or female aged 18 + years;
•clinical assessment of max 5 actinic keratoses on face, scalp and/ or hands
•mild to moderate actinic keratosis lesions (AK I + II) up to 1,5 cm in diameter
•minimal distance between lesions of 1,5 cm
•physical examination without further disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
•skin type I – IV (Fitzpatrick)
•women with childbearing potential must use a reliable method of contraception which result in a low failure rate (i.e. less than 1% per year) like implants, injectables, combines oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomised partner
•pregnancy test negative (in women with childbearing potential)
•physical ability to apply the product correctly
•written informed consent obtained.

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

·Subjects are to be excluded from the study when one or more of the following conditions are met:
•Acute or pre-existing Basal cell carcinoma, BCC or Squamous cell carcinoma, SCC
•Treatment with topical treatment (e.g. Diclofenac/ Solaraze®) within the past 4 weeks
•Treatment with PDT within the past 3 month
•Indication to perform a biopsy for histological diagnostic
•„Cornu cutaneum-like phenomena in treatment area
•Non-responder to previous 5-FU treatment
•Erosion or ulcera in the application area
•Acute skin inflammation in the target area
•Indication for immunosuppressive drugs (e.g. Methotrexat, Sulfonylharnstoff)
•Indication for treatment with Brivudin (Zostex®) within the past 4 weeks (interaction with 5-FU)
•Known lack of Dihydropyrimidine dehydrogenase (DPD) activity
•Indication for treatment with Phenytoin (Phenhydan®, Phenytoin-AWD®, Zentropil®) within the past 4 weeks (interaction with 5-FU)
•Pregnancy or breastfeeding
•Known renal insufficiency
•evidence of drug or alcohol abuse;
•symptoms of another clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
•participation in another clinical study in the 4 weeks preceding the study;
•known allergic reactions to components of the study preparations
•treatment with systemic or locally acting medications which might counter or influence the study aim
•in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable non-compliance or inability to understand the study and give adequately informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: clinical efficacy;Secondary Objective: tolerability, PGA, patient assessment & compliance;Primary end point(s): improvement in clinical score