Status:
COMPLETED
Photodynamic Therapy With PD P 506 A Compared With Placebo-PDT for the Treatment of AK
Lead Sponsor:
photonamic GmbH & Co. KG
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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-expos...
Eligibility Criteria
Inclusion
- Written informed consent
- Caucasian patients
- Diagnosis of actinic keratosis (AK) with at least three locally separated lesions located on head and/or face (hairless areas)
- Selected AK study lesions have clearly defined margins and are mild to moderate
- 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
- 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 PDT
- Pre-treatment of the AK lesions eligible for study procedures during the 2 weeks preceding PDT with keratolytic agents e.g. TCA, urea or salicylic acid containing formulations
- Pre-treatment with hypericin during the 2 weeks preceding PDT
- Treatment with systemic retinoids during the 3 months preceding PDT
- Treatment with cytostatics or radiation during the 3 months preceding PDT
- 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 PDT
- Skin sun sensitivity type V or VI according to Fitzpatrick
- Known intolerance to one or more of the ingredients of the study medication
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00308854
Start Date
March 1 2006
End Date
December 1 2007
Last Update
April 11 2008
Active Locations (7)
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1
Praxis Dr. Popp Dipl.-Med. Weber
Augsburg, Germany, 86179
2
Dermatologisches Zentrum Berlin
Berlin, Germany, 14129
3
Praxisklinik Professor Dr. Uwe Reinhold
Bonn, Germany, 53225
4
Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
Frankfurt a.M., Germany, 60590