Safety and efficacy of IDEA-070 for the treatment of pain and inflammation induced by photodynamic therapy of actinic keratosis - Effect of IDEA-070 on pain and inflammation induced by PDT
- Conditions
- Patients suffering from actinic keratosis to be treated with PDT
- Registration Number
- EUCTR2005-002875-34-DE
- Lead Sponsor
- IDEA AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Diagnosis of actinic keratosis to be treated with PDT
- affecting equal sized areas of both sides of the head
- affecting at least 10% of the area of photo-exposure
Aged 18-85 years
Reliable method of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intraueterine-devices, sexual abstinence or vasectomised partner)
Willing to obstain from excessive sun/UV exposure during the course of the study
Are the trial subjects under 18?
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
Other clinically relevant dermal or systemic diseases including malignancy
Major hypertrophy of lesions
Porphyria
Topical treatment with 5-FU, cryotherapy, PDT, diclophenac sodium, and other less common treatments on the treatment area or systemic treatment within 3 months prior to screening
Immunosuppressants within 2 weeks prior to screening
Concomitant use of topical immunmodulators, other analgesics including topical NSAIDs, retinoids, antioxidants
Known sensitisation to NSAIDs
Photoallergy
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