Clinical trial NCT02362152: The Real Life Topical Field Treatment of Actinic Keratosis Study
Official title: The Real Life Topical Field Treatment of Actinic Keratosis Study. An Observational Study Focusing on Patient Reported Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratosis
Keywords: Actinic keratosis
Solar keratosis
Field treatment
Ingenol mebutate
Picato
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-02-12
Enrollment: 1168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with actinic keratosis planned to receive treatment with ingenol mebutate, 5-fluorouracil, imiquimod or diclofenac at the discretion of the dermatologist (and patient).

Brief summary: 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: 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.

Eligibility criteria: 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.

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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.

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Primary outcomes:
measure: Treatment satisfaction
timeFrame: 3-4 weeks after end of treatment
Secondary outcomes:
measure: Adherence
timeFrame: 3-4 weeks after end of treatment
measure: Health Related Quality of Life EQ-5D-5L
timeFrame: Baseline and 3-4 weeks after end of treatment
measure: DLQI
timeFrame: Baseline and 3-4 weeks after end of treatment
measure: WPAI
timeFrame: 3-4 weeks after end of treatment
measure: Local Skin Response
timeFrame: Up to 3-4 weeks after end of treatment
Other outcomes:
Locations:
city: Bergen op Zoom
country: Netherlands
facility: Lievensberg Ziekenhuis
Study officials:
affiliation: LEO Pharma
name: Study Director Study Director
role: STUDY_DIRECTOR
References: