actinic keratosis MedDRA version: 8.1 Level: LLT Classification code 10000614 Term: Actinic keratosis
Conditions
Interventions
Trade Name: Verrumal Lösung
Product Name: Verrumal Lösung
Pharmaceutical Form: Spot-on solution
INN or Proposed INN: 5-Fluorouracil
CAS Number: 51-21-8
Current Sponsor code: 5-FU
Concentration unit: g
Sponsors
Hermal Kurt Herrmann GmbH & Co OHG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: clinical efficacy;Secondary Objective: tolerability, PGA, patient assessment & compliance;Primary end point(s): improvement in clinical score | — |
Countries
Germany
Outcome results
None listed