Back to resultsEfficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
LAS41007 o.d.
LAS41007 b.i.d.
LAS106521
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, AK, NMSC
Eligibility 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
Sites / Locations
- Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
LAS41007 o.d.
LAS41007 b.i.d.
LAS106521
Arm Description
Once daily
Twice daily
Outcomes
Primary Outcome Measures
Histological clearance of one pre-selected target lesion
Complete clinical clearance of all target lesions in the treatment areas
Secondary Outcome Measures
Physician's Global Tolerability Assessment (PGT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00991861
Brief Title
Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis, AK, NMSC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LAS41007 o.d.
Arm Type
Experimental
Arm Description
Once daily
Arm Title
LAS41007 b.i.d.
Arm Type
Experimental
Arm Description
Twice daily
Arm Title
LAS106521
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
LAS41007 o.d.
Intervention Description
Once daily, topical application
Intervention Type
Drug
Intervention Name(s)
LAS41007 b.i.d.
Intervention Description
Twice daily, topical application
Intervention Type
Drug
Intervention Name(s)
LAS106521
Intervention Description
Twice daily, topical application
Primary Outcome Measure Information:
Title
Histological clearance of one pre-selected target lesion
Time Frame
Day 120
Title
Complete clinical clearance of all target lesions in the treatment areas
Time Frame
Day 120
Secondary Outcome Measure Information:
Title
Physician's Global Tolerability Assessment (PGT)
Time Frame
Day 120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Willers, MD, MBA
Organizational Affiliation
Almirall Hermal GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.almirall.com/webcorp2/cda/ImD_04_02.jsp
Description
Almirall Corporate Website
Learn more about this trial
Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis
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