The aim of this study is to investigate whether PD P 506 A-PDT is effective in treating mild to moderate AK lesions located on the head.
Actinic keratosis (AK) is a pre-cancerous skin abnormality usually caused by sun exposure. Actinic keratoses occur most commonly in fair skin, especially in the elderly. They mainly occur in sun-exposed skin areas like head and hands. It is standard of care to remove AK when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (PDT). A direct comparison versus placebo which is necessary for the exact quantification of the effect of PD P 506 A has not yet been performed and is subject of this study protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
107
Praxis Dr. Popp Dipl.-Med. Weber
Augsburg, Germany
Dermatologisches Zentrum Berlin
Berlin, Germany
Praxisklinik Professor Dr. Uwe Reinhold
Bonn, Germany
Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
Frankfurt a.M., Germany
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after PDT
Time frame: 12 weeks
CCR on patient basis 12 weeks, 6, 9 and 12 months after PDT
Time frame: 12 months
CCR of treated actinic keratosis lesions 6, 9 and 12 months after PDT
Time frame: 12 months
Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy
Time frame: 12 months
Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of successful clearance and no recurrence of the lesion
Time frame: 12 months
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SciDerm
Hamburg, Germany
Dermatologisches Ambulatorium Hamburg-Alstertal
Hamburg, Germany
Gemeinschaftspraxis Dres. Scholz/Sebastian/Schilling
Mahlow, Germany