Aktinic Keratosis Stage II and III. MedDRA version: 7.1 Level: LLT Classification code 10000614
Conditions
Interventions
Product Name: HDP 99.0006
Pharmaceutical Form: Capsule*
INN or Proposed INN: Fosfluridine tidoxil
CAS Number: RN174638-187
Current Sponsor code: HDP 99.0006
Concentration unit: mg milligram(s)
Concent
Sponsors
Heidelberg Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Actinic Keratosis stage II (hyperkeratotic epidermal lesions on skin overexposed to the sun), confirmed by biopsy. - Actinic Keratosis stage III (severe hyperkeratotic epidermal lesions on skin overexposed to the sun), confirmed by biopsy. - 10 or more lesions. The lesions should be located in the face, the balding scalp, the dorsal forearm or the back of the hands - Male or non-lactating, non-pregnant females. Female patients of childbearing potential must have a negative pregnancy test and use at least one form of contraception as approved by the Investigator for four weeks prior to receiving the first dose of study medication and six months after the last study dose is administered. Male patients with a female partner of childbearing potential should use a form of contraception as approved by the Investigator during the study and for six months after the last study dose is administered - 55 years of age or older - Ability to co-operate 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 or diseases which are contraindications for the use of Fluorouracil - Using any immunmodulaters, cytotoxic drugs or investigational drugs 4 weeks before Visit 2 - Confirmed or suspected bacterial or viral infection less than 3 weeks before Visit 2· - Diagnosed as having hematologic, hepatic or gastroinestinal abnormalities or diseases - 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)· Clinical evidence for HBV or HCV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of different doses of HDP 99.0006 on actinic keratosis;Secondary Objective: To evaluate the safety and tolerance of 3 cycles of different doses of HDP 99.0006 ;Primary end point(s): The primary variable is the percentage change in the number of AK lesions at visit 15, compared to baseline. | — |
Countries
Germany
Outcome results
None listed