Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis
- Conditions
- Actinic Keratosis
- Interventions
- Drug: LAS106521Drug: Placebo GelDrug: LAS41005
- Registration Number
- NCT00987246
- Lead Sponsor
- Almirall, S.A.
- 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 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 470
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LAS106521 LAS106521 - Placebo Placebo Gel - LAS41005 LAS41005 -
- Primary Outcome Measures
Name Time Method Histological status of AK target lesion Day 140
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
Almirall Facility Site#01
🇩🇪Berlin, Germany
Almirall Facility Site#04
🇩🇪Buxtehude, Germany
Almirall Facility Site#30
🇩🇪Dresden, Germany
Almirall Facility Site#28
🇩🇪Berlin, Germany
Almirall Facility Site#21
🇩🇪Landau, Germany
Almirall Facility Site#27
🇩🇪Leipzig, Germany
Almirall Facility Site#37
🇩🇪Altenkirchen, Germany
Almirall Facility Site#24
🇩🇪Augsburg, Germany
Almirall Facility Site#02
🇩🇪Berlin, Germany
Almirall Facility Site#34
🇩🇪Berlin, Germany
Almirall Facility Site#23
🇩🇪Augsburg, Germany
Almirall Facility Site#35
🇩🇪Berlin, Germany
Almirall Facility Site#31
🇩🇪Bonn, Germany
Almirall Facility Site#40
🇩🇪Detmold, Germany
Almirall Facility Site#11
🇩🇪Dülmen, Germany
Almirall Facility Site#12
🇩🇪Düsseldorf, Germany
Almirall Facility Site#17
🇩🇪Frankfurt, Germany
Almirall Facility Site#36
🇩🇪Friedrichshafen, Germany
Almirall Facility Site#22
🇩🇪Freiburg, Germany
Almirall Facility Site#19
🇩🇪Fulda, Germany
Almirall Facility Site#09
🇩🇪Hamburg, Germany
Almirall Facility Site#32
🇩🇪Göttingen, Germany
Almirall Facility Site#29
🇩🇪Jena, Germany
Almirall Facility Site#07
🇩🇪Kiel, Germany
Almirall Facility Site#08
🇩🇪Kiel, Germany
Almirall Facility Site#06
🇩🇪Lübeck, Germany
Almirall Facility Site#03
🇩🇪Mahlow, Germany
Almirall Facility Site#25
🇩🇪München, Germany
Almirall Facility Site#33
🇩🇪Nördlingen, Germany
Almirall Facility Site#38
🇩🇪Osnabrück, Germany
Almirall Facility Site#39
🇩🇪München, Germany
Almirall Facility Site#05
🇩🇪Pinneberg, Germany
Almirall Facility Site#26
🇩🇪Quedlinburg, Germany
Almirall Facility Site#14
🇩🇪Vechta, Germany
Almirall Facility Site#16
🇩🇪Soest, Germany
Almirall Facility Site#13
🇩🇪Wuppertal, Germany
Almirall Facility Site#18
🇩🇪Wiesbaden, Germany
Almirall Facility Site#20
🇩🇪Radolfzell, Germany
Almirall Facility Site#10
🇩🇪Salzwedel, Germany
Almirall Facility Site#15
🇩🇪Koblenz, Germany