RAPID-ACT Study
Research type
Research Study
Full title
The Real Life Topical Treatment of Actinic Keratosis Study
IRAS ID
153278
Contact name
John Lear
Contact email
Sponsor organisation
LEO Pharma
Duration of Study in the UK
0 years, 4 months, 15 days
Research summary
Actinic Keratosis (Ak) is a pre-cancerous skin disease caused by exposure to ultra violet radiation. It occurs on areas of the skin most exposed to sunlight for example the scalp, the face, the back of the hands and the arms. AK has the potenial to regress to normal skin or progress into squamous skin carcinoma. The steady increase in skin cancer incidences both cutanwous malignant melanoma and non-melanoma skin can cancer has become a rapidly growing health burden worldwide. It is estimated between 11-25% of the population with higher estmiates in the southern hemisphere.
Treatment effects and satisfaction are important outcomes of AK treatment as there is a high probability of having multiple consecutive lesions, therefore treatment regimes during a patient's lifetime.The available topical treatments differ on several aspects, such as mechanism of action, administration and length of treatment. These aspects may influence treatment satisfaction and real life treatment effects.
This study will analuse patient reported outcomes in terms of treatment satisfaction, treatment adherence, work and activity impairment and health related quality of life. The study will focus on four types of topical treatment commonly prescribed by clinicians, 5-fluorouracil, imiquimod, diclofenac and ingenol mebutance in a real life setting.
In order to be eligible for the study participants must be over 18 years old nad be able to receive one of the above topical treatments for AK. If patients decide to proceed they will complete a series of questionnaires at their inital clinical appointment. They will then complete the treatment course as per standard clinical practice and three to four weeks after treatment completion they will complete a second series of questionnaires.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/1165
Date of REC Opinion
9 Oct 2014
REC opinion
Further Information Favourable Opinion