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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987246
• Other study ID #: H 1005 6002 - 0702
• Secondary ID: EudraCT: 2007-00
• Status: Completed
• Phase: Phase 3
• First received: September 29, 2009
• Last updated: July 27, 2015
• Start date: June 2008
• Est. completion date: June 2009

Study information

• 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

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of LAS41005 in comparison to placebo and to LAS106521 in actinic keratosis (AK).

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 information / eligibility

• 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Placebo Gel
Topical
• LAS41005
Topical
• LAS106521
Topical

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological status of AK target lesion		Day 140	No

External Links

•   Sponsor website