Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis

Phase 3

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: LAS106521; Drug: Placebo Gel; Drug: 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

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

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)

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

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