Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
NCT ID: NCT01821391
Last Updated: 2021-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
131 participants
INTERVENTIONAL
2013-07-31
2014-03-31
Brief Summary
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The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
* Metvix NDL-PDT / Metvix c-PDT
* Metvix NDL-PDT / Placebo c-PDT
TREATMENT
SINGLE
Study Groups
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NDL-PDT/c-PDT
Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
NDL-PDT
Metvix natural daylight photodynamic therapy
c-PDT
Metvix conventional photodynamic therapy
NDL-PDT/placebo c-PDT
Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy
NDL-PDT
Metvix natural daylight photodynamic therapy
placebo c-PDT
Metvix placebo conventional photodynamic therapy
Interventions
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NDL-PDT
Metvix natural daylight photodynamic therapy
c-PDT
Metvix conventional photodynamic therapy
placebo c-PDT
Metvix placebo conventional photodynamic therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject with two symmetrical treated areas half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs
Exclusion Criteria
* Subject with pigmented AK on the treated areas
* Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons
* Subject with porphyria,
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Nicole Basset Seguin, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Hopital Saint Louis France
Bibiana Perez Garcia, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Ramón y Cajal Spain
Rianne Gerritsen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Radboud University, Nijmegen Medical Center The Netherlands
Rolf-Markus Sziemies, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Klinik fur Dermatologie und Allergologie Germany
Ingrid Synnerstad, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Hudmottagningen Sweden
Locations
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Investigative site
Montpellier, , France
Investigational site
Nantes, , France
Investigational site
Nice, , France
Investigational site
Paris, , France
Investigative site
Rennes, , France
Investigational site
Aachen, , Germany
Investigational site
Berlin, , Germany
Investigational site
Münster, , Germany
Investigational site
Recklinghausen, , Germany
Investigational site
Assen, , Netherlands
Investigational site
Maastricht, , Netherlands
Investigational site
Nijmegen, , Netherlands
Investigational site
Huesca, , Spain
Investigational site
Madrid, , Spain
Investigative site
Pamplona, , Spain
Investigational site
Valencia, , Spain
Investigational site
Karlskoga, , Sweden
Investigational site
Norrköping, , Sweden
Countries
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Other Identifiers
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RD.03.SPR.29112
Identifier Type: -
Identifier Source: org_study_id
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