- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00269074
Effect of IDEA-070 on Pain and Inflammation Induced by PDT
Safety and Efficacy of IDEA-070 for the Treatment of Pain and Inflammation Induced by Photodynamic Therapy of Actinic Keratosis
Study Overview
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Nordrhein-Westfalen
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Duesseldorf, Nordrhein-Westfalen, Germany, D-40225
- Dermatological department of university hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Diagnosis ot actinic keratosis to be treated with PDT affecting equal sized areas of both sides of the head affecting at least 10% of the area of photoexposure
Exclusion Criteria:
Morpheaform basal cell carcinoma, Major hypertrophy of lesions, Porphyria, Topical treatment with 5-FU, cryotherapy, PDT, diclophenac sodium, and other less common treatments on the treatment area or systemic treatment within 3 month prior to screening, Concomitant use of other analgesics including topical NSAIDs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia Reifenberger, PD Dr. med., Dermatological department of university Duesseldorf
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL-070-II-02
- EudrCT number: 2005-002875-34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Northwestern UniversityWithdrawn
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Tulane UniversityMayne Pharma International Pty LtdTerminatedActinic KeratosesUnited States
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Medical University of ViennaTerminatedActinic KeratosesAustria
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University Hospital RegensburgGerman Research FoundationCompleted
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St Vincent's University Hospital, IrelandCompleted
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