The Real Life Topical Field Treatment of Actinic Keratosis Study

Study Overview
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Brief Summary
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This non-interventional, multinational study of topical field treatment of actinic keratosis (AK) aims to collect real-life experience with ingenol mebutate as well as one or two other topical field therapies commonly used in the individual country. Physicians will report baseline characteristics, while the main study focus will be on patient reported outcomes 3-4 weeks after treatment completion (treatment satisfaction, adherence, resource utilization and Health Related Quality of Life. Dermatology centres in Denmark, Norway, Sweden, the Netherlands, the United Kingdom and Canada will participate.

Detailed Description
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Actinic keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to squamous cell carcinoma. AK treatment options include cryotherapy for solitary lesions and topical field therapy or photodynamic therapy for lesions in an area of sun-damaged skin. This prospective, non-interventional, multinational study aims to describe and compare in a real-life setting the treatment satisfaction, treatment adherence, resource utilization and quality of life during topical field treatment of AK with 5-fluorouracil, imiquimod, diclofenac and ingenol mebutate. Dermatology centres in Denmark, Sweden, Norway, Canada, the United Kingdom and the Netherlands will aim to include a total of approximately 1600 patients, of which around 100 in each country will be patients scheduled to receive treatment with ingenol mebutate. In each country patients will in addition be recruited for one or two of the other treatment arms, as appropriate in the country. Only adult patients scheduled to start treatment with imiquimod, 5-fluorouracil, diclofenac or ingenol mebutate who have given informed consent to use data from their medical records for the study and to report study data themselves will be included and followed for the duration of the scheduled treatment + 3-4 weeks. Physician will report patient demographics and AK characteristics at baseline. Patients will at baseline report AK Quality of Life, including general attitude regarding sun damaged skin at baseline, and, if applicable, treatment satisfaction and adherence with latest previous AK treatment. At 3-4 weeks after end of treatment, the patients will report treatment satisfaction, adherence, resource utilization, health related Quality of Life. Treating physicians report drug-related Adverse Events in accordance with national laws and regulations and normal clinical practice.

Official Title
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The Real Life Topical Field Treatment of Actinic Keratosis Study. An Observational Study Focusing on Patient Reported Outcomes

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Ingenol mebutate
* Drug: 5-fluorouracil
* Drug: Imiquimod
* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients eligible to receive topical treatment with one of the following for treatment of actinic keratosis at the discretion of the dermatologist: Ingenol mebutate, 5-fluorouracil, imiquimod, diclofenac. Informed consent. - Exclusion Criteria: Any on-going treatments at study start with ingenol mebutate, 5-fluorouracil, imiquimod or diclofenac; other topical treatment for AK in treatment area; pregnancy or planned pregnancy within treatment period. -

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ingenol mebutate<br>Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments | Drug: Ingenol mebutate<br>* Topical field treatment as prescribed by dermatologist<br>* Other names: Picato;|
| 5-fluorouracil<br>Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments | Drug: 5-fluorouracil<br>* Topical field treatment as prescribed by dermatologist<br>* Other names: 5-FU;|
| Imiquimod<br>Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments | Drug: Imiquimod<br>* Topical field treatment as prescribed by dermatologist<br>|
| Diclofenac<br>Adults with actinic keratosis eligible to receive topical treatment with one of the four treatments | Drug: Diclofenac<br>* Topical field treatment as prescribed by dermatologist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction | Treatment Satisfaction Questionnaire of Medication TSQM 9 | 3-4 weeks after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Morisky Medication Adherence Scale | 3-4 weeks after end of treatment | 
| Health Related Quality of Life EQ-5D-5L | General measure of health outcome | Baseline and 3-4 weeks after end of treatment | 
| DLQI | Dermatology Life Quality Index | Baseline and 3-4 weeks after end of treatment | 
| WPAI | Work Productivity and Activity Impairment Questionnaire | 3-4 weeks after end of treatment | 
| Local Skin Response | Occurrence and duration of redness of skin, dry skin, burning, or stinging | Up to 3-4 weeks after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic keratosis, Solar keratosis, Field treatment, Ingenol mebutate, Picato