Double-blind, randomized, multi-centre phase II study to evaluate the efficacy and safety of topically applied LAS41007 once daily and LAS41007 twice daily versus Solaraze® 3% gel twice daily in the treatment of actinic keratosis grade I to II - LAS41007
- Conditions
- Patients aged 18 and older suffering from actinic keratoses. Patients to be considered have at least four and up to ten actinic keratoses of grade I to grade II in two treatment blocks of 25 cm2 each within the face/forehead (excluding eyelids, lips and mucosa) or bald scalp.MedDRA version: 9.1Level: LLTClassification code 10000614Term: Actinic keratosis
- Registration Number
- EUCTR2009-012063-33-DE
- Lead Sponsor
- Almirall Hermal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
- caucasian male and female patients prepared and able to give written informed consent
- physical ability to comply to the study preparations correctly and to follow the study restrictions and visits
- ages eligible for study: 18 years and older
- Actinic keratoses (AK) with a diameter of 0,5 to 1.5 cm, that are definitively distinguished from other lesions and display a minimum distance of 1 cm to neighbored lesions. The AK lesions to be treated, at least four but not more than 10, need to be of mild to moderate intensity (grade I to grade II) and located in overall two treatment blocks with a size 25 cm2 each, within the face/forehead (excluding eyelids, lips and mucosa) or bald scalp. For histological confirmation (of clearance) of the AK diagnosis a pre- and post-treatment punch biopsy is taken.
- women of childbearing potential will not be considered unless they use a highly effective method of contraception (failure rate of less than 1% per year)
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
- Have known hypersensitivity, intolerance or allergies against diclofenac sodium or other ingredients of the investigational medicinalproducts and other non-steroidal antirheumatic agents.
- Have a history of bronchospasm, asthma, urticaria, or rhinitis after the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
- Have a history of gastrointestinal bleeding or perforation associated with prior therapy with NSAIDs.
- Have evidence of clinically significant or unstable medical conditions such as: (a) metastatic tumor or tumor with high probability of metastatic spread, (b) heart failure (NYHA class III or higher), (c) immunosuppressive disorder (e.g. HIV), (d) hematologic, hepatic, renal, neurologic or endocrine disorder, (e) collagen-vascular disorder (e.g. cerebro-vascular disorder or other bleedings), (f) gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage).
- Within the treatment areas other malignant or benign skin tumors, Cornu cutaneum and/or hypertrophic AK lesions are observed.
- Any clinically relevant abnormal finding regarding the laboratory assessment performed at Screening (only applicable for two study centers; to be reviewed at baseline).
- Suffer from paresthesia in the treatment areas.
- Within 6 weeks prior to Day 1 and throughout the study topical treatment in the target area(s) with topical preparations containing retinoids, steroids, 5-fluorouracil or topical immunomodulators.
- Within 6 weeks prior to Day 1 and throughout the study, topical treatment in the target area(s) with diclofenac preparations other than the investigational medicinal product(s) (IMPs).
- Throughout the study, topical treatments with diclofenac preparations outside the target area are prohibited. Exception: if needed only occasionally and not as permanent therapy (pro re nata, = 3 days at a strech; e.g. Voltaren® Emulgel).
- Within 6 weeks prior to Day 1 and throughout the study, systemic treatment with diclofenac.
- Within 6 months prior to Day 1 and throughout the study, systemic treatment with retinoids, interferon, cytotoxic drugs.
- Within 3 months prior to Day 1 and throughout the study, systemic treatment with 5-fluorouracil preparations, drugs known to have major organ toxicity and immunomodulators or immunosuppressive therapies.
- Within 4 weeks prior to Day 1 and throughout the study, systemic treatment with oral, injectable corticosteroids. The same applies for inhaled corticosteroids, if the daily dose for beclomethasone exceeds 1200 µg/day or 600 µg/day for fluticasone.
- Physical treatments in the treatment areas such as surgical excision (except biopsy for diagnostic confirmation), cryo-, thermo- or chemodestruction and photodynamic therapy within 6 weeks prior to Day 1 and throughout the study.
- Curettage in the treatment areas within 4 weeks prior to Day 1 and throughout the study.
- Patients who need a permanent therapy with any other NSAID. The use of NSAIDs as prn” (pro re nata), i.e. to be taken as needed (= 3 days at a stretch) and the use of ASA as anticoagulative therapy (see below) will be allowed.
- Patients taking methotrexate or sulfonylurea.
- Anticoagulative therapy with Marcumar throughout the study. Treatment with ASA at a dose not exceeding 100 mg/d and clopidogrel at a dose not exceeding 75 mg/d will be allowed.
- Patients having any significant physical abnormalities in the potential treatment areas that may cause diffi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method