A Double-Blind Phase II Study of HDP 99.0006 in Patients with Actinic Keratosis - A Double-Blind Phase II Study of HDP 99.0006 in Patients with Actinic Keratosis
- Conditions
- Aktinic Keratosis Stage II and III.MedDRA version: 7.1Level: LLTClassification code 10000614
- Registration Number
- EUCTR2005-000394-21-DE
- Lead Sponsor
- Heidelberg Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br><br><br>;Primary end point(s): The primary variable is the percentage change in the number of AK lesions at visit 15, compared to baseline.
- Secondary Outcome Measures
Name Time Method