PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK
Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis
2 other identifiers
interventional
349
1 country
26
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. To be able to quantify the effect the patient will be allocated to one of three treatments: PD P 506 A-PDT, cryosurgery or placebo-PDT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2006
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 29, 2006
CompletedFirst Posted
Study publicly available on registry
March 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedApril 11, 2008
April 1, 2008
1.3 years
March 29, 2006
April 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment.
12 weeks
Secondary Outcomes (4)
CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment
12 months
CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment
12 months
Adverse events/reactions and local reactions during application of the study medication as well as during and after study therapy (PDT or cryosurgery)
12 months
Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of no recurrence of the lesion
12 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Suspected lack of compliance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber
Augsburg, 86179, Germany
Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin
Berlin, 10117, Germany
Praxis Dr. Simon
Berlin, 10827, Germany
Gemeinschaftspraxis Dres. Steinert
Biberach, 88400, Germany
Elbekliniken Dermatologisches Zentrum
Buxtehude, 21614, Germany
Gemeinschaftspraxis Dr. Dominicus, Dr. Bockhorst
Dülmen, 48249, Germany
Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin
Frankfurt a.M., 60590, Germany
Gemeinschaftspraxis Prof. Melnik, H. Hariry
Gütersloh, 33330, Germany
Gemeinschaftspraxis PD Dr. Petering, Dr. Röhrig-Petering
Hildesheim, 31134, Germany
Gemeinschaftspraxis Dr. Denzer-Fürst, Dr. Kietzmann
Kiel, 24103, Germany
Gemeinschaftspraxis Dr. Schirren, Dr. Lischner, Dr. Podszuweit
Kiel, 24103, Germany
Tagesklinik für Allergie- u. Hautkrankheiten
Kiel, 24148, Germany
Praxis Dr. Habermann
Koblenz, 56068, Germany
Praxis Dr. Fritz
Landau, 76829, Germany
Gemeinschaftspraxis PD Dr. Plötz, Prof. Dr. Abeck
München, 81545, Germany
Praxis Dr. Tanner
Nördlingen, 86720, Germany
Praxis Dr. Nickel
Pfungstadt, 64319, Germany
Praxis Dr. Itschert
Pinneberg, 25421, Germany
Praxis Dr. Rozsondai
Radolfzell, 78315, Germany
Praxis Dr. Gehse
Rastatt, 76437, Germany
Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie
Regensburg, 93053, Germany
Praxis Dr. Karl
Soest, 59494, Germany
Praxis Dr. Datz
Tübingen, 72072, Germany
Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch
Vechta, 49377, Germany
Praxis Dr. Imberger
Westerland, 25980, Germany
Praxis PD Dr. Dirschka
Wuppertal, 42275, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rolf-Marcus Szeimies, Professor MD
Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 29, 2006
First Posted
March 30, 2006
Study Start
March 1, 2006
Primary Completion
June 1, 2007
Study Completion
November 1, 2007
Last Updated
April 11, 2008
Record last verified: 2008-04