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Tracking Information | |||||
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First Received Date † | March 29, 2006 | ||||
Last Updated Date | April 10, 2008 | ||||
Start Date † | March 2006 | ||||
Current Primary Outcome Measures † |
Complete clinical clearance rate (CCR) of treated actinic keratosis lesions 12 weeks after study treatment. [ Time Frame: 12 weeks ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00308867 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | PD P 506 A-PDT Versus Placebo-PDT and Cryosurgery for the Treatment of AK | ||||
Official Title † | Photodynamic Therapy With PD P 506 A or Its Placebo Compared With Cryosurgery for the Treatment of Mild to Moderate Actinic Keratosis | ||||
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. |
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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-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. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Actinic Keratosis | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 349 | ||||
Completion Date | November 2007 | ||||
Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Germany | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00308867 | ||||
Responsible Party | |||||
Secondary IDs †† | EudraCT No. 2005-003556-36 | ||||
Study Sponsor † | photonamic GmbH & Co. KG | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | photonamic GmbH & Co. KG | ||||
Verification Date | April 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |