Actinic Keratosis Clinical Trial
Official title:
The Real Life Topical Field Treatment of Actinic Keratosis Study. An Observational Study Focusing on Patient Reported Outcomes
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.
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.
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