Actinic Keratosis are scaling epidermal lesions, which consist of dysplastic keratinocytes. They mostly appear in pale-skinned patients which are chronically overexposed to UV radiation. Actinic keratosis is a precancerous epidermal lesion, which can progress into a squamous cell carcinoma. According to Guenthner et al., 97% of squamous cell carcinomas (a nonmelanoma skin cancer) were associated with a cohesive AK lesion MedDRA version: 8.1 Level: LLT Classification code 10000614 Term: Actinic
Conditions
Interventions
Product Name: Fosfluridine tidoxil
Product Code: HDP 99.0006
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: fosfluridine tidoxil
Current Sponsor code: HDP 99.0006
Concentration unit: % (W/W)
Sponsors
Heidelberg Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 10 or more lesions. The lesions should be located in the face and/or the balding scalp - Actinic keratosis grade II (moderately thick AK, easily felt and seen on skin overexposed to the sun) or Actinic keratosis grade III (hyperkeratotic, very thick and/or obvious AK on skin overexposed to the sun), confirmed by biopsy taken from the most progressed lesion - Postmenopausal female 50 years of age or older with a documented amneorrhoe of at least 2 years - Males of 50 years of age or older. Male patients with a female partner of childbearing potential should use a form of contraception (e.g. condoms) as approved by the investigator for the treatment period and for at least 4 weeks after the last study dose is administered - Ability to comply with treatment - Signed informed consent prior to start of any study specific procedures 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: - Concomitant severe diseases - Known or suspected hypersensitivity to Fluorouracil - Pretreatment with any therapy for AK lesions less than 4 weeks before Visit 2 (Baseline) - Use of any immunomodulators, cytotoxic drugs or investigational drugs within 4 weeks before Visit 2 (Baseline) - Patients who are using drugs which may effect dihydropyrimidine dehydrogenase activity (e.g. Brivudine, Sorivudine) or using calcium folinates (e.g. Leucovorin®) - Pretreatment with Omeprazol or other proton pump inhibitors within the last week before Visit 2 (Baseline) - Confirmed or suspected acute bacterial or acute viral infection less than 3 weeks before Visit 2 (Baseline) - Diagnosed as having clinically relevant hematologic abnormalities or diseases, with haemoglobin, hematocrit, red blood cells, white blood cells, absolute neutrophil count, platelets 1.5 x UNL - Diagnosed as having hepatic or gastrointestinal abnormalities or diseases - Dependency on alcohol or other drugs - Patients with malabsorption syndromes affecting drug absorption - Patients who cannot swallow or patients with conditions that may hamper compliance and/or absorption of the tested product - Major thoracic and/or abdominal surgery in the preceding 6 weeks before Visit 2 - No adequate hepatic function (bilirubin > 1.5 x UNL or alkaline phosphatase or transaminases > 2.5 x UNL) - No adequate renal function (serum creatinine > 1.5 x UNL) - History of or clinical evidence for Hepatitis B infection (if evidence is seen this should be confirmed laboratory tests on HBs-Ag, HBc antibodies or HBs antibodies) - History of or clinical evidence for Hepatitis C infection (if evidence is seen this should be confirmed laboratory tests on HCV antibodies) - History of or clinical evidence for HIV infection (if evidence is seen this should be confirmed laboratory tests on HIV antibodies) - Any concomitant condition that could compromise the objectives of this study and the patient’s compliance - Within the last six weeks, basal cell skin cancer within 10 cm from the study area chosen for the assessment of actinic keratosis - Squamous cell carcinoma, porokeratosis, acute rosacea or any stage of lentigo maligna - Patients with a homozygous inherited deficiency in Dihydropyrimidine dehydrogenase (DPD) activity - Participation in another clinical trial within the last 4 weeks - Unavoidable high exposure to sunshine or sunlamps expected during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to evaluate the efficacy of Fosfluridine tidoxil in patients with actinic keratosis.;Secondary Objective: The secondary study objective is to evaluate tolerability and safety of Fosfluridine tidoxil in patients with actinic keratosis. ;Primary end point(s): Percentage change from baseline compared to Visit 16 (Day 169) in the number of AK lesions in the observation site (the face and/or the balding scalp) | — |
Countries
Germany
Outcome results
None listed