Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis
18 Years
N/A
Both
Actinic Keratosis
Trial Information
Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis
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). In Europe, cryosurgery is the method primarily used and will
therefore serve as comparator therapy for PD P 506 A-PDT. A placebo control will be
necessary to validate the test system. While the comparison of PD P 506 A-PDT and
cryosurgery is an open comparison, placebo-PDT and PD P 506 A-PDT will be allocated in a
double-blind manner.
Inclusion Criteria:
- Written informed consent
- Caucasians
- Age > 18 years
- Diagnosis of actinic keratosis (AK) with at least four locally separated lesions
located on head and/or face (hairless areas)
- Selected AK study lesions have clearly defined margins and are mild to moderate
(grades I or II)
- The distance between the study lesion borders is > 1.0 cm
- Maximum diameter of each study lesion is 1.8 cm
- Skin sun sensitivity type I to IV according to Fitzpatrick
Exclusion Criteria:
- PDT Non-responder
- Pre-treatment of the AK lesions eligible for study procedures with pharmaceuticals
approved for the treatment of AK during the 4 weeks preceding study treatment
- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks
preceding study treatment with keratolytic agents e.g. TCA, urea or salicylic acid
containing formulations
- Pre-treatment with hypericin during the 2 weeks preceding study therapy
- Treatment with systemic retinoids during the 3 months preceding study therapy
- Treatment with cytostatics or radiation during the 3 months preceding study therapy
- Female patients of childbearing potential
- Patients with clinically relevant suppression of the immune system
- Diagnosis of Porphyria
- Skin diseases that might interfere with response evaluation of study treatment
- Skin sun sensitivity type V or VI according to Fitzpatrick
- Known intolerance to one or more of the ingredients of the study medication
- Known adverse reactions to cryosurgery (including cold urticaria and cold
intolerance)
- Dementia or psychic condition that might interfere with the ability to understand the
study and thus give a written informed consent
- Simultaneous participation in another clinical study or participation in another
clinical study in the 30 days directly preceding inclusion
- Suspected lack of compliance
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.
Outcome Time Frame:
12 weeks
Principal Investigator
Rolf-Marcus Szeimies, Professor MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
AK 04
NCT ID:
NCT00308867
Start Date:
March 2006
Completion Date:
November 2007
Related Keywords:
- Actinic Keratosis
- PDT
- AK
- Cryosurgery
- Keratosis
- Keratosis, Actinic
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