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

May 28, 2015 updated by: Almirall, S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histological clearance of one pre-selected target lesion
Time Frame: Day 120
Day 120
Complete clinical clearance of all target lesions in the treatment areas
Time Frame: Day 120
Day 120

Secondary Outcome Measures

Outcome Measure
Time Frame
Physician's Global Tolerability Assessment (PGT)
Time Frame: Day 120
Day 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Almirall, S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H 569 000 - 0908
  • EudraCT: 2009-012063-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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