Status:
COMPLETED
Efficacy and Safety Study of LAS41007 in the Treatment of Actinic Keratosis
Lead Sponsor:
Almirall, S.A.
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00991861
Start Date
August 1 2009
End Date
February 1 2010
Last Update
May 29 2015
Active Locations (1)
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1
Investigational Site
Hamburg, Germany