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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


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
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Recruiting NCT03684772 - Topical Ionic Contra-Viral Therapy in Actinic Keratosis Phase 2
Completed NCT02878382 - Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT N/A
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