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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991861
First Posted: October 8, 2009
Last Update Posted: May 29, 2015
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.
Information provided by (Responsible Party):
Almirall, S.A.
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
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): NCT00991861


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

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT00991861     History of Changes
Other Study ID Numbers: H 569 000 - 0908
EudraCT: 2009-012063-33
First Submitted: October 7, 2009
First Posted: October 8, 2009
Last Update Posted: May 29, 2015
Last Verified: May 2015

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

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