Status:
COMPLETED
PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery 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 how the efficacy and tolerability of PD P 506 A-PDT relate to the commonly used cryosurgery in the treatment of 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
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT00308867
Start Date
March 1 2006
End Date
November 1 2007
Last Update
April 11 2008
Active Locations (26)
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1
Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber
Augsburg, Germany, 86179
2
Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin
Berlin, Germany, 10117
3
Praxis Dr. Simon
Berlin, Germany, 10827
4
Gemeinschaftspraxis Dres. Steinert
Biberach, Germany, 88400