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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT00987246
First received: September 29, 2009
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

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


Condition Intervention Phase
Actinic Keratosis
Drug: Placebo Gel
Drug: LAS41005
Drug: LAS106521
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Histological status of AK target lesion [ Time Frame: Day 140 ] [ Designated as safety issue: No ]

Enrollment: 470
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAS41005 Drug: LAS41005
Topical
Active Comparator: LAS106521 Drug: LAS106521
Topical
Placebo Comparator: Placebo Drug: Placebo Gel
Topical

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987246

Locations
Germany
Almirall Facility Site#37
Altenkirchen, Germany, 57610
Almirall Facility Site#23
Augsburg, Germany, 86179
Almirall Facility Site#24
Augsburg, Germany, 86163
Almirall Facility Site#01
Berlin, Germany, 10117
Almirall Facility Site#02
Berlin, Germany, 10827
Almirall Facility Site#28
Berlin, Germany, 10437
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#39
München, Germany, 81476
Almirall Facility Site#25
München, Germany, 80337
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

Additional Information:
No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT00987246     History of Changes
Other Study ID Numbers: H 1005 6002 - 0702, EudraCT: 2007-003889-18
Study First Received: September 29, 2009
Last Updated: July 27, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on August 27, 2015