Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis
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
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 7, 2009
CompletedFirst Posted
Study publicly available on registry
October 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMay 29, 2015
May 1, 2015
6 months
October 7, 2009
May 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Histological clearance of one pre-selected target lesion
Day 120
Complete clinical clearance of all target lesions in the treatment areas
Day 120
Secondary Outcomes (1)
Physician's Global Tolerability Assessment (PGT)
Day 120
Study Arms (3)
LAS41007 o.d.
EXPERIMENTALOnce daily
LAS41007 b.i.d.
EXPERIMENTALTwice daily
LAS106521
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Almirall, S.A.lead
Study Sites (1)
Investigational Site
Hamburg, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christoph Willers, MD, MBA
Almirall Hermal GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2009
First Posted
October 8, 2009
Study Start
August 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
May 29, 2015
Record last verified: 2015-05