Actinic Keratosis Clinical Trial
Official title:
Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II
Verified date | July 2015 |
Source | Almirall, S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).
Status | Completed |
Enrollment | 470 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Main Inclusion Criteria: - Have at least 4 but not more than 10 clinically confirmed AK target lesions of mild to moderate intensity within the face/forehead or bald scalp (excluding eyelids, lips, and mucosa), i.e. actinic keratosis grade I and II according to Olsen EA et al. 1991 - Woman of childbearing potential are allowed to participate in this study only if they use a highly effective method of contraception Main Exclusion Criteria: - Have received effective treatment of AK in the three months preceding this clinical trial - 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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Almirall Facility Site#37 | Altenkirchen | |
Germany | Almirall Facility Site#23 | Augsburg | |
Germany | Almirall Facility Site#24 | Augsburg | |
Germany | Almirall Facility Site#01 | Berlin | |
Germany | Almirall Facility Site#02 | Berlin | |
Germany | Almirall Facility Site#28 | 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 | |
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 |
Lead Sponsor | Collaborator |
---|---|
Almirall, S.A. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Histological status of AK target lesion | Day 140 | No |
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