Condition category
Skin and Connective Tissue Diseases
Date applied
04/11/2015
Date assigned
05/11/2015
Last edited
05/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Massimo Milani

ORCID ID

http://orcid.org/0000-0001-7559-1202

Contact details

Viale Abruzzi 3
Milan
20123
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ery-02-2015

Study information

Scientific title

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

Acronym

Study hypothesis

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.

Ethics approval

IFO - Regina Elena - San Gallicano Hospital Rome (Italy), November 2014

Study design

Randomised parallel-group assessor-blinded prospective trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Actinic keratosis

Intervention

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

Intervention type

Device

Phase

Drug names

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

01/01/2014

Overall trial end date

02/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Presence of at least 5 AK lesions on the scalp

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

30

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

01/01/2014

Recruitment end date

30/06/2014

Locations

Countries of recruitment

Italy

Trial participating centre

IFO - Regina Elena - San Gallicano Hospital Dermatology and Oncology Division
Rome
00100
Italy

Sponsor information

Organisation

IFO Hospital (Italy)

Sponsor details

-
Rome
00100
Italy

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

IFO Hospital (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

Publication citations

Additional files

Editorial Notes