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

Hermal Kurt Herrmann GmbH & Co OHG0 sites15 target enrollmentDecember 21, 2006

Overview

No summary available.

Registry

who.int

Start Date

December 21, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•·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

•·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)