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 23, 2012
Last verified: July 2012
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987246

Sponsors and Collaborators
Almirall, S.A.
Investigators
Study Director: Christoph Willers, 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 23, 2012
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
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014