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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: LAS41007 o.d.
* Drug: LAS41007 b.i.d.
* Drug: LAS106521


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAS41007 o.d.<br>Once daily | Drug: LAS41007 o.d.<br>* Once daily, topical application<br>|
| Experimental: LAS41007 b.i.d.<br>Twice daily | Drug: LAS41007 b.i.d.<br>* Twice daily, topical application<br>|
| Active Comparator: LAS106521<br> | Drug: LAS106521<br>* Twice daily, topical application<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Tolerability Assessment (PGT) |  | Day 120 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AK, Actinic Keratosis, NMSC