Use of sunscreens with DNA repair components are more efficacious that sunscreen only in improving keratosis actinica patients clinical outcome after photodynamic therapy
| ISRCTN | ISRCTN12347628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12347628 |
| Secondary identifying numbers | Ery-02-2015 |
- Submission date
- 04/11/2015
- Registration date
- 05/11/2015
- Last edited
- 29/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Scientific
Viale Abruzzi 3
Milan
20123
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|
Study information
| Study design | Randomised parallel-group assessor-blinded prospective trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | IFO - Regina Elena - San Gallicano Hospital Rome (Italy), November 2014 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/01/2014 |
| Completion date | 02/02/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | Presence of at least 5 AK lesions on the scalp |
| Key exclusion criteria | 1. Presence of non-melanoma skin cancer lesions 2. Allergy to one of the components of study products 3. Xerodema pigmentosum |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
00100
Italy
Sponsor information
Hospital/treatment centre
-
Rome
00100
Italy
"ROR" |
https://ror.org/04j6jb515 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The plan is to publish the study in a peer-reviewed Journal |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2016 | 29/05/2020 | Yes | No |
Editorial Notes
29/05/2020: Publication reference added.
