LAS41005 in Hyperkeratotic Actinic Keratosis

Study Overview
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Brief Summary
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The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).

Official Title
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A Prospective Comparator Controlled Randomized Exploratory Study on the Efficacy of LAS 41005 Compared to Cryotherapy in Subjects With Hyperkeratotic Actinic Keratosis

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Procedure: Cryotherapy
* Drug: LAS41005


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Signed and dated written informed consent. Men and women aged between 18 and 85 years inclusive. Have a general good and stable health condition as confirmed by a physical examination and by medical history. Have at least 4 but not more than 10 clinically confirmed hyperkeratotic AK target lesions of moderate to severe intensity within the face/forehead or bald scalp Skin type I to IV according to Fitzpatrick's . Are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation. Physical ability to apply the study preparation correctly and to follow the study restrictions and visit. Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception Main Exclusion Criteria: Have received treatment of AK within the treatment area (face / scalp) in the three months preceding this clinical trial. Have known hypersensitivity to the ingredients Are subjects under immunosuppressive therapy. Having coagulation defects which are inherited or acquired Have evidence of clinically significant, unstable medical conditions Have currently other malignant or benign tumors of the skin within the treatment area Subjects who have taken topical or systemic treatments that might interfere with the study end points, within a time window that is not allowed, or who are currently taking phenytoin, methotrexate or sulfonylurea. Subjects taking inhibitors of DPD (e.g. Brivudin, Sorivudin) Are known to be pregnant or lactating (currently or within the past 3 months). Have any dermatological disease in the treatment area or surrounding area that may be exacerbated by treatment Are currently or within the past 8 weeks participating in another clinical study. Have active chemical dependency or alcoholism as assessed by the investigator. Subject is institutionalized because of legal or regulatory order.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug Las41005 | Drug: LAS41005<br>* once daily<br>|
| Other: 2<br>Cryotherapy | Procedure: Cryotherapy<br>* 1-2 times during the treatment time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological status (AK diagnosis and grade) of one predefined target lesion | Histological clearance at 8 weeks after end of treatment with LAS 41005, respectively 14 weeks after first cryotherapy. Histological Status will be measured by Histological Biopsy in order to confirm the diagnosis of AK and the grade. | Screening and 8 weeks after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Actinic keratoses (AK)lesion count at each visit | The clearance rate (complete/partial) of AK lesions (determined by clinical evaluation) in the treatment area (target areas A and B) will be measured by comparing the total AK lesion counts pre-treatment (on Day 1 before study treatment has been applied) with the lesion counts measured. | day 1, day 21, day 42 and day 98. |