PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK
This study has been completed.
Sponsor:
photonamic GmbH & Co. KG
Information provided by:
photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00308867
First received: March 29, 2006
Last updated: April 10, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Actinic Keratosis |
Procedure: Photodynamic Therapy Procedure: Cryosurgery |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis |
Further study details as provided by photonamic GmbH & Co. KG:
Primary Outcome Measures:
- Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment. [ Time Frame: 12 weeks ]
Secondary Outcome Measures:
- CCR on patient basis 12 weeks, 6, 9 and 12 months after study treatment [ Time Frame: 12 months ]
- CCR of treated actinic keratosis lesions 6, 9 and 12 months after study treatment [ Time Frame: 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) [ Time Frame: 12 months ]
- Satisfaction and independent cosmetic rating of the cleared study lesions by patient and investigator in case of no recurrence of the lesion [ Time Frame: 12 months ]
| Enrollment: | 349 |
| Study Start Date: | March 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308867
Locations
| Germany | |
| Gemeinschaftspraxis Dr. Popp, Dipl.-Med. Weber | |
| Augsburg, Germany, 86179 | |
| Klinik für Dermatologie, Venerologie und Allergologie der Charite, Universitätsmedizin Berlin | |
| Berlin, Germany, 10117 | |
| Praxis Dr. Simon | |
| Berlin, Germany, 10827 | |
| Gemeinschaftspraxis Dres. Steinert | |
| Biberach, Germany, 88400 | |
| Elbekliniken Dermatologisches Zentrum | |
| Buxtehude, Germany, 21614 | |
| Gemeinschaftspraxis Dr. Dominicus, Dr. Bockhorst | |
| Duelmen, Germany, 48249 | |
| Zentrum Dermatologie und Venerologie, Klinikum und Fachbereich Medizin | |
| Frankfurt a.M., Germany, 60590 | |
| Gemeinschaftspraxis Prof. Melnik, H. Hariry | |
| Guetersloh, Germany, 33330 | |
| Gemeinschaftspraxis PD Dr. Petering, Dr. Röhrig-Petering | |
| Hildesheim, Germany, 31134 | |
| Gemeinschaftspraxis Dr. Denzer-Fürst, Dr. Kietzmann | |
| Kiel, Germany, 24103 | |
| Gemeinschaftspraxis Dr. Schirren, Dr. Lischner, Dr. Podszuweit | |
| Kiel, Germany, 24103 | |
| Tagesklinik für Allergie- u. Hautkrankheiten | |
| Kiel, Germany, 24148 | |
| Praxis Dr. Habermann | |
| Koblenz, Germany, 56068 | |
| Praxis Dr. Fritz | |
| Landau, Germany, 76829 | |
| Gemeinschaftspraxis PD Dr. Plötz, Prof. Dr. Abeck | |
| Muenchen, Germany, 81545 | |
| Praxis Dr. Tanner | |
| Noerdlingen, Germany, 86720 | |
| Praxis Dr. Nickel | |
| Pfungstadt, Germany, 64319 | |
| Praxis Dr. Itschert | |
| Pinneberg, Germany, 25421 | |
| Praxis Dr. Rozsondai | |
| Radolfzell, Germany, 78315 | |
| Praxis Dr. Gehse | |
| Rastatt, Germany, 76437 | |
| Klinikum der Universität Regensburg, Klinik und Poliklinik für Dermatologie | |
| Regensburg, Germany, 93053 | |
| Praxis Dr. Karl | |
| Soest, Germany, 59494 | |
| Praxis Dr. Datz | |
| Tuebingen, Germany, 72072 | |
| Gemeinschaftspraxis Dr. Borrosch, Dr. Jasnoch | |
| Vechta, Germany, 49377 | |
| Praxis Dr. Imberger | |
| Westerland, Germany, 25980 | |
| Praxis PD Dr. Dirschka | |
| Wuppertal, Germany, 42275 | |
Sponsors and Collaborators
photonamic GmbH & Co. KG
Investigators
| Principal Investigator: | Rolf-Marcus Szeimies, Professor MD | Klinikum der Universität Regensburg, Kinik und Poliklinik für Dermatologie |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00308867 History of Changes |
| Other Study ID Numbers: | AK 04, EudraCT No. 2005-003556-36 |
| Study First Received: | March 29, 2006 |
| Last Updated: | April 10, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by photonamic GmbH & Co. KG:
|
PDT AK Cryosurgery |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013