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Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis

This study has been completed.
Information provided by (Responsible Party):
Almirall, S.A. Identifier:
First received: October 7, 2009
Last updated: May 28, 2015
Last verified: May 2015
The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.

Condition Intervention Phase
Actinic Keratosis Drug: LAS41007 o.d. Drug: LAS41007 b.i.d. Drug: LAS106521 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Multi-centre Phase II Study to Evaluate the Efficacy and Safety of Topically Applied LAS41007 Once Daily and LAS41007 Twice Daily Versus LAS106521 Gel Twice Daily 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 clearance of one pre-selected target lesion [ Time Frame: Day 120 ]
  • Complete clinical clearance of all target lesions in the treatment areas [ Time Frame: Day 120 ]

Secondary Outcome Measures:
  • Physician's Global Tolerability Assessment (PGT) [ Time Frame: Day 120 ]

Estimated Enrollment: 100
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAS41007 o.d.
Once daily
Drug: LAS41007 o.d.
Once daily, topical application
Experimental: LAS41007 b.i.d.
Twice daily
Drug: LAS41007 b.i.d.
Twice daily, topical application
Active Comparator: LAS106521 Drug: LAS106521
Twice daily, topical application


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 4-10 clinically assessed actinic keratosis grade I to II (according to Olsen et al, 1991) in the face/forehead and/or on the bald scalp
  • The diameter of each AK target lesion is not less than 0.5 cm and not greater than 1.5 cm
  • The target lesions must be located in overall 2 treatment areas with a size of 25 cm2 per treatment area

Exclusion Criteria:

  • Have evidence of clinically significant or unstable medical conditions such as:

    • metastatic tumor or tumor with high probability of metastatic spread
    • heart failure (NYHA class III or higher)
    • immunosuppressive disorder (e.g. HIV)
    • hematologic, hepatic, renal, neurologic or endocrine disorder.
    • collagen-vascular disorder (e.g. cerebrovascular disorder or other bleedings).
    • gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage)
  • Suffer from paresthesia in the treatment areas
  • Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas
  Contacts and Locations
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Please refer to this study by its identifier: NCT00991861

Investigational Site
Hamburg, Germany
Sponsors and Collaborators
Almirall, S.A.
Study Director: Christoph Willers, MD, MBA Almirall Hermal GmbH
  More Information

Responsible Party: Almirall, S.A. Identifier: NCT00991861     History of Changes
Other Study ID Numbers: H 569 000 - 0908
EudraCT: 2009-012063-33
Study First Received: October 7, 2009
Last Updated: May 28, 2015

Keywords provided by Almirall, S.A.:
Actinic Keratosis

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms processed this record on September 21, 2017