Status:
COMPLETED
Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis
Lead Sponsor:
Almirall, S.A.
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).
Detailed Description
To investigate as primary objective: * Superiority to placebo and non-inferiority to LAS106521 measured by histological clearance of one predefined target lesion; To investigate as secondary objecti...
Eligibility Criteria
Inclusion
- Main
- 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
- 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT00987246
Start Date
June 1 2008
End Date
June 1 2009
Last Update
July 28 2015
Active Locations (40)
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1
Almirall Facility Site#37
Altenkirchen, Germany, 57610
2
Almirall Facility Site#24
Augsburg, Germany, 86163
3
Almirall Facility Site#23
Augsburg, Germany, 86179
4
Almirall Facility Site#01
Berlin, Germany, 10117