Clinical trial NCT00987246: Study on the Efficacy of LAS41005 in the Treatment of Actinic Keratosis
Official title: Study on the Efficacy of LAS41005 Compared to Placebo and to LAS106521 in the Treatment of Actinic Keratosis Grade I to II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
AK
NMSC
Combination
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Histological status of AK target lesion
timeFrame: Day 140
Secondary outcomes:
Other outcomes:
Locations:
city: Altenkirchen
country: Germany
facility: Almirall Facility Site#37
city: Augsburg
country: Germany
facility: Almirall Facility Site#24
city: Augsburg
country: Germany
facility: Almirall Facility Site#23
city: Berlin
country: Germany
facility: Almirall Facility Site#01
city: Berlin
country: Germany
facility: Almirall Facility Site#28
city: Berlin
country: Germany
facility: Almirall Facility Site#02
city: Berlin
country: Germany
facility: Almirall Facility Site#34
city: Berlin
country: Germany
facility: Almirall Facility Site#35
city: Bonn
country: Germany
facility: Almirall Facility Site#31
city: Buxtehude
country: Germany
facility: Almirall Facility Site#04
city: Detmold
country: Germany
facility: Almirall Facility Site#40
city: Dresden
country: Germany
facility: Almirall Facility Site#30
city: Dülmen
country: Germany
facility: Almirall Facility Site#11
city: Düsseldorf
country: Germany
facility: Almirall Facility Site#12
city: Frankfurt
country: Germany
facility: Almirall Facility Site#17
city: Freiburg
country: Germany
facility: Almirall Facility Site#22
city: Friedrichshafen
country: Germany
facility: Almirall Facility Site#36
city: Fulda
country: Germany
facility: Almirall Facility Site#19
city: Göttingen
country: Germany
facility: Almirall Facility Site#32
city: Hamburg
country: Germany
facility: Almirall Facility Site#09
city: Jena
country: Germany
facility: Almirall Facility Site#29
city: Kiel
country: Germany
facility: Almirall Facility Site#07
city: Kiel
country: Germany
facility: Almirall Facility Site#08
city: Koblenz
country: Germany
facility: Almirall Facility Site#15
city: Landau
country: Germany
facility: Almirall Facility Site#21
city: Leipzig
country: Germany
facility: Almirall Facility Site#27
city: Lübeck
country: Germany
facility: Almirall Facility Site#06
city: Mahlow
country: Germany
facility: Almirall Facility Site#03
city: München
country: Germany
facility: Almirall Facility Site#25
city: München
country: Germany
facility: Almirall Facility Site#39
city: Nördlingen
country: Germany
facility: Almirall Facility Site#33
city: Osnabrück
country: Germany
facility: Almirall Facility Site#38
city: Pinneberg
country: Germany
facility: Almirall Facility Site#05
city: Quedlinburg
country: Germany
facility: Almirall Facility Site#26
city: Radolfzell
country: Germany
facility: Almirall Facility Site#20
city: Salzwedel
country: Germany
facility: Almirall Facility Site#10
city: Soest
country: Germany
facility: Almirall Facility Site#16
city: Vechta
country: Germany
facility: Almirall Facility Site#14
city: Wiesbaden
country: Germany
facility: Almirall Facility Site#18
city: Wuppertal
country: Germany
facility: Almirall Facility Site#13
Study officials:
affiliation: Almirall Hermal GmbH
name: Estrella Garcia, MD, MBA
role: STUDY_DIRECTOR
References: