Plain English Summary
Background and study aims
Actinic keratoses (AK) are dry scaly patches of skin caused by damage from years of exposure to sunlight. Photodynamic therapy (PDT) is a well-established treatment for AK that involves the use of a light-sensitive medication and a light source to destroy abnormal cells. After PDT sun-protection strategies are important in order to reduce the risk of new lesions and/or the need for more PDT. A film-forming medical device containing photolyase, a DNA-repairing enzyme with a light-protective action, has been developed (called Ery). The aim of this study is to assess the clinical effects of Ery in comparison with a commercially available sunscreen (SS) in AK patients after successful PDT for the treatment of AK lesions of the scalp.
Who can participate?
AK patients with at least five AK lesions on the scalp.
What does the study involve?
Participants are randomly allocated to be treated with either Ery or SS. The number of new AK lesions and the need to perform more PDT are evaluated at 1, 3 6 and 9 months after PDT.
What are the possible benefits and risks of participating?
The study products may help in reducing the risk of developing new AK lesions. No specific risks are associated with the use of the two products.
Where is the study run from?
IFO - Regina Elena - San Gallicano Hospital Dermatology and Oncology Division (Italy)
When is the study starting and how long is it expected to run for?
January 2014 to February 2015
Who is funding the study?
IFO Hospital (Italy)
Who is the main contact?
Dr Massimo Milani
Dr Massimo Milani
Viale Abruzzi 3
A 9-month, randomised, assessor-blinded parallel-group study to evaluate clinical effects of a film-forming medical devices containing photolyase in the treatment of cancerization field in comparison with sunscreen in patients after successful photodynamic therapy for actinic keratosis
To assess and compare the clinical effects of a sunscreen containing a DNA-repair substance on the evolution of actinic keratosis (AK) in comparison with a commercially available sunscreen (SS) in AK subjects after a successful photodynamic therapy (PDT) for the treatment of AK lesions of the scalp.
IFO - Regina Elena - San Gallicano Hospital Rome (Italy), November 2014
Randomised parallel-group assessor-blinded prospective trial
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Patients are randomised to be treated with either:
1. A film-forming class II medical device containing photolyase, a DNA-repairing enzyme, with a high broad photo-protection action (Ery)
2. A commercially available sunscreen
Primary outcome measures
Evolution of AK lesions after successful PDT, evaluated at baseline and at 1, 3 6 and 9 months after PDT
Secondary outcome measures
Need for additional PDT procedure, evaluated at baseline and at 1, 3 6 and 9 months after PDT
Overall trial start date
Overall trial end date
Participant inclusion criteria
Presence of at least 5 AK lesions on the scalp
Target number of participants
Participant exclusion criteria
1. Presence of non-melanoma skin cancer lesions
2. Allergy to one of the components of study products
3. Xerodema pigmentosum
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
IFO - Regina Elena - San Gallicano Hospital Dermatology and Oncology Division
IFO Hospital (Italy)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
The plan is to publish the study in a peer-reviewed Journal
Intention to publish date
Participant level data
Available on request
Results - basic reporting