Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis
NCT ID: NCT00987246
Last Updated: 2015-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
470 participants
INTERVENTIONAL
2008-06-30
2009-06-30
Brief Summary
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Detailed Description
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* Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion;
To investigate as secondary objective:
* Superiority to LAS106521
* Improvement of treated lesions (lesion response)
* Assessment of tolerability and safety by physicians global assessment score (PGA, PGT)
* Patient's assessment of tolerability and efficacy and patient's compliance
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LAS41005
LAS41005
Topical
LAS106521
LAS106521
Topical
Placebo
Placebo Gel
Topical
Interventions
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Placebo Gel
Topical
LAS41005
Topical
LAS106521
Topical
Eligibility Criteria
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Inclusion Criteria
* Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception
Exclusion Criteria
* Have known hypersensitivity to LAS41005 or LAS106521
* Have currently other malignant or benign tumors of the skin within the treatment area (e.g. malignant melanoma, basal cell carcinoma, squamous cell carcinoma)
* Patient's taking phenytoin
* Show cornu cutaneum like alterations of the skin in the face or the bald scalp (target area)
18 Years
85 Years
ALL
No
Sponsors
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Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Estrella Garcia, MD, MBA
Role: STUDY_DIRECTOR
Almirall Hermal GmbH
Locations
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Almirall Facility Site#37
Altenkirchen, , Germany
Almirall Facility Site#24
Augsburg, , Germany
Almirall Facility Site#23
Augsburg, , Germany
Almirall Facility Site#01
Berlin, , Germany
Almirall Facility Site#28
Berlin, , Germany
Almirall Facility Site#02
Berlin, , Germany
Almirall Facility Site#34
Berlin, , Germany
Almirall Facility Site#35
Berlin, , Germany
Almirall Facility Site#31
Bonn, , Germany
Almirall Facility Site#04
Buxtehude, , Germany
Almirall Facility Site#40
Detmold, , Germany
Almirall Facility Site#30
Dresden, , Germany
Almirall Facility Site#11
Dülmen, , Germany
Almirall Facility Site#12
Düsseldorf, , Germany
Almirall Facility Site#17
Frankfurt, , Germany
Almirall Facility Site#22
Freiburg im Breisgau, , Germany
Almirall Facility Site#36
Friedrichshafen, , Germany
Almirall Facility Site#19
Fulda, , Germany
Almirall Facility Site#32
Göttingen, , Germany
Almirall Facility Site#09
Hamburg, , Germany
Almirall Facility Site#29
Jena, , Germany
Almirall Facility Site#07
Kiel, , Germany
Almirall Facility Site#08
Kiel, , Germany
Almirall Facility Site#15
Koblenz, , Germany
Almirall Facility Site#21
Landau, , Germany
Almirall Facility Site#27
Leipzig, , Germany
Almirall Facility Site#06
Lübeck, , Germany
Almirall Facility Site#03
Mahlow, , Germany
Almirall Facility Site#25
München, , Germany
Almirall Facility Site#39
München, , Germany
Almirall Facility Site#33
Nördlingen, , Germany
Almirall Facility Site#38
Osnabrück, , Germany
Almirall Facility Site#05
Pinneberg, , Germany
Almirall Facility Site#26
Quedlinburg, , Germany
Almirall Facility Site#20
Radolfzell, , Germany
Almirall Facility Site#10
Salzwedel, , Germany
Almirall Facility Site#16
Soest, , Germany
Almirall Facility Site#14
Vechta, , Germany
Almirall Facility Site#18
Wiesbaden, , Germany
Almirall Facility Site#13
Wuppertal, , Germany
Countries
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Related Links
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Sponsor website
Other Identifiers
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EudraCT: 2007-003889-18
Identifier Type: -
Identifier Source: secondary_id
H 1005 6002 - 0702
Identifier Type: -
Identifier Source: org_study_id
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