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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00987246
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Placebo Gel Drug: LAS41005 Drug: LAS106521 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: LAS41005 Drug: LAS41005
Topical
Active Comparator: LAS106521 Drug: LAS106521
Topical
Placebo Comparator: Placebo Drug: Placebo Gel
Topical


Outcome Measures

Primary Outcome Measures :
  1. Histological status of AK target lesion [ Time Frame: Day 140 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987246


Locations
Germany
Almirall Facility Site#37
Altenkirchen, Germany, 57610
Almirall Facility Site#24
Augsburg, Germany, 86163
Almirall Facility Site#23
Augsburg, Germany, 86179
Almirall Facility Site#01
Berlin, Germany, 10117
Almirall Facility Site#28
Berlin, Germany, 10437
Almirall Facility Site#02
Berlin, Germany, 10827
Almirall Facility Site#34
Berlin, Germany, 10967
Almirall Facility Site#35
Berlin, Germany, 12353
Almirall Facility Site#31
Bonn, Germany, 53111
Almirall Facility Site#04
Buxtehude, Germany, 21614
Almirall Facility Site#40
Detmold, Germany, 32756
Almirall Facility Site#30
Dresden, Germany, 01097
Almirall Facility Site#11
Dülmen, Germany, 48249
Almirall Facility Site#12
Düsseldorf, Germany, 40225
Almirall Facility Site#17
Frankfurt, Germany, 60590
Almirall Facility Site#22
Freiburg, Germany, 79104
Almirall Facility Site#36
Friedrichshafen, Germany, 88045
Almirall Facility Site#19
Fulda, Germany, 36037
Almirall Facility Site#32
Göttingen, Germany, 37075
Almirall Facility Site#09
Hamburg, Germany, 20148
Almirall Facility Site#29
Jena, Germany, 07740
Almirall Facility Site#07
Kiel, Germany, 24103
Almirall Facility Site#08
Kiel, Germany, 24105
Almirall Facility Site#15
Koblenz, Germany, 56068
Almirall Facility Site#21
Landau, Germany, 76829
Almirall Facility Site#27
Leipzig, Germany, 04103
Almirall Facility Site#06
Lübeck, Germany, 23538
Almirall Facility Site#03
Mahlow, Germany, 15831
Almirall Facility Site#25
München, Germany, 80337
Almirall Facility Site#39
München, Germany, 81476
Almirall Facility Site#33
Nördlingen, Germany, 86720
Almirall Facility Site#38
Osnabrück, Germany, 49078
Almirall Facility Site#05
Pinneberg, Germany, 25421
Almirall Facility Site#26
Quedlinburg, Germany, 06484
Almirall Facility Site#20
Radolfzell, Germany, 78315
Almirall Facility Site#10
Salzwedel, Germany, 29410
Almirall Facility Site#16
Soest, Germany, 59494
Almirall Facility Site#14
Vechta, Germany, 49377
Almirall Facility Site#18
Wiesbaden, Germany, 65191
Almirall Facility Site#13
Wuppertal, Germany, 42275
Sponsors and Collaborators
Almirall, S.A.
Investigators
Study Director: Estrella Garcia, MD, MBA Almirall Hermal GmbH
More Information

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT00987246     History of Changes
Other Study ID Numbers: H 1005 6002 - 0702
EudraCT: 2007-003889-18
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Almirall, S.A.:
Actinic Keratosis
AK
NMSC
Combination

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms