Prospective, randomized study of the efficacy of photodynamic therapy in actinic keratosis - PDT in AK

niv.-Prof. Dr. Hans F. Merk, Dept. of Dermatology, University Hospital, RWTH Aachen University0 sites100 target enrollmentOctober 14, 2008

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: niv.-Prof. Dr. Hans F. Merk, Dept. of Dermatology, University Hospital, RWTH Aachen University
Enrollment: 100
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

October 14, 2008

End Date

March 16, 2010

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niv.-Prof. Dr. Hans F. Merk, Dept. of Dermatology, University Hospital, RWTH Aachen University

•Patients who comply with the following criteria will be selected for the study:
•\- Willing and able to sign informed consent form.
•\- Men aged between 45 to 85 years.
•\- Postmenopausal women (at least 3 years postmenopausal, 45 to 85 years)
•\- Histologically or clinically confirmed diagnosis of actinic keratosis grade I (mild actinic keratosis: better palpable \[skin roughness], than visible) and grade II (moderate actinic keratosis: palpable \[roughness] and visible \[red macula or papule with mild keratosis]) of the face and scalp. A histopathologic assessment will be performed in case of doubt to exclude basal cell carcinoma, squamous cell carcinoma, actinic porokeratosis or lentigo\-maligna.
•\- Have a good and stable health condition on the basis of the entrance examination and patient history.
•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

•Patients may not participate if they meet any of the following criteria:
•\- Women and men under the age of 45 years.
•\- Premenopausal, pregnant or breastfeeding women (currently or within the past 3 months)
•\- History of or clinically proven photodermatoses, porphyria, hypersensitivity to porphyrins or generally known photosensitivity.
•\- Use of topical medications such as topical steroids, retinoids, imiquimod or 5\-fluorouracil within 3 months before the start of the study.
•\- Immunosuppressive medication (corticosteroids, methotrexate, cyclosporine, azathioprine, chemotherapy, immunotherapy ect.) within 3 months before the start of the study.
•\- Laser resurfacing or chemical peelings of the areas to be treated within 2 months before inclusion in the study.
•\-Treatment with photosenzitising drugs like psoralenes, tetracyclines, nalidixic acid, furosemide, amiodarone, phenothiacines, chinolons, fibrates, phytotherapy with St. John\`s wart, arnica, valerian or topically applied phototoxic substances like tar, psoralenes or some dyes like thiazide, methylene blue, toluidine blue, eosine, Bengal red, or acridine.
•\- Known allergies, hypersensitivity reactions or intolerance to the drug and the ingredients of the 10% BF\-200 ALA\-gel: soy lecithine, polysorbate 80, caprylic/capric acid triglycerides, isopropyl alcohol, disodium phosphate dihydrate, sodium hydroxide, propylene glycole, sodium benzoate.
•\- Simultaneous participation in other studies.