Plain English Summary
Background and study aims
Actinic keratosis (AK) is a common pre-cancer (with increased risk of developing into cancer) skin change that is caused by due to sun exposure over many years with no sun protection. AK appears as patches of thick, scaly, or crusty skin that feel rough or dry. Several treatments are available for this skin condition. Photodynamic therapy (PDT) using a photosensitizer (a drug that is activated only in the areas of AK using a special type of light), can cure AK patches. After PDT has cleared the AK, patients must protect their skin from the sun to prevent AK coming back. In this study (called ATHENA), we want to test a cream containing sunscreen and piroxicam (a drug that can reduce the risk of skin cancer) in comparison to standard sunscreen-only products in preventing AK coming back after PDT.
Who can participate?
Adults who have at least 6 patches of AK on their scalp or face.
What does the study involve?
All patients will be treated with PDT. They will be randomly allocated to apply to either sunscreen alone or sunscreen containing piroxicam to the affected area twice daily for 6 days.
What are the possible benefits and risks of participating?
If the piroxicam-containing sunscreen is more effective than sunscreen alone in preventing AK coming back, then the participants in this group will benefit from a reduced need for PDT, which can be time-consuming and painful. The standard prevention is to use sunscreen, so participants in the sunscreen-only group will not receive worse treatment than if they were not in the study. There is no increased risk of side effects for the sunscreen containing piroxicam.
Where is the study run from?
Erba-Rinaldi Hospital and DermoLaser Office Verona.
When is the study starting and how long is it expected to run for?
March 2017 to April 2018
Who is funding the study?
The study is funded by Cantabria Labs Difa Cooper, the company that makes the sunscreen containing piroxicam.
Who is the main contact?
Dr Massimo Milani, massimo.milani@difacooper.com
Trial website
Contact information
Type
Public
Primary contact
Dr Massimo Milani
ORCID ID
http://orcid.org/0000-0001-7559-1202
Contact details
Via Milano 160
Caronno Pertusella
21042
Italy
+39029659031
massimo.milani@difacooper.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ACTX-01-2017
Study information
Scientific title
The ATHENA Trial: Actixicam after photo-dynamic therapy for multiple actinic keratosis lesions. A randomized open-label assessor-masked outcome evaluation superiority trial vs. standard care in actinic keratosis subjects after phtotodynamic therapies
Acronym
ATHENA
Study hypothesis
After photodynamic therapy (PDT) for multiple actinic keratosis (AK), lesion photoprotection strategies (i.e. use of sunscreen) is mandatory in order to reduce actinic damage and recurrence of new lesions. Recurrence of new AK lesions after PDT are common after 6-9 months after PDT. A sunscreen cream (SPF50+) containing piroxicam 0.8% has shown to be effective in reducing AK lesions as a monotherapy. There are no data comparing different photoprotection strategies (i.e sunscreen only, sunscreen with photolyase etc) comparing the efficacy in reducing AK recurrence after PDT. In this study, we wanted to assess if the use of SPF50+ and piroxicam cream could be more effective than standard photoprotection in reducing recurrence of AK after successful PDT.
Ethics approval
IRB Dermolaser Clinic, Verona, Italy, 15/01/2017, RS: 01-DLC-17
Study design
Pragmatic randomized open-label assessor-masked trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Actinic keratosis recurrence after photodynamic therapy
Intervention
Randomization was performed using a randomization list with an allocation ratio of 1:1.
Actixicam: sunscreen SPF50+ and piroxicam 0.8% cream formulation, applied twice daily 0.5 g (1 finger tip unit) per application for 6 consecutive days after successful PDT
Sunscreen: sunscreen cream (SPF50+ or SPF100+ and photolyase) applied twice daily 0.5 g (1 finger tip unit) per application for 6 consecutive days after successful PDT
Intervention type
Drug
Phase
Drug names
Piroxicam
Primary outcome measure
Clinical count (assessor masked for allocation treatments) of actinic keratosis lesions 6 months after last PDT session
Secondary outcome measures
Local tolerability (patient’s self-reported complaints e.g. burning, itching etc) will be evaluated at visit 2 (1 month after baseline visit), at visit 2 (3 months after baseline) and at visit 3 (6 months after baseline)
Overall trial start date
01/12/2016
Overall trial end date
25/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. At least 6 AK lesions (scalp or face) suitable for PDT treatment
2. Aged >18 years
3. Willing to participate in the trial (giving written informed consent)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
64 evaluable subject
Total final enrolment
68
Participant exclusion criteria
1. Other acute skin diseases other than AK
2. Known allergy to one of the components of products used in the trial
Recruitment start date
01/03/2017
Recruitment end date
30/09/2017
Locations
Countries of recruitment
Italy
Trial participating centre
Erba-Rinaldi Hospital
Dermatology Unit
Erba-Rinaldi Hospital
Via Casartelli Menaggio
Menaggio
20126
Italy
Trial participating centre
DermoLaser Office Verona
Piazza Cittadella
Verona
10090
Italy
Sponsor information
Organisation
Cantabria Labs Difa Cooper
Sponsor details
Via Milano 160
Caronno Pertusella
21042
Italy
+39029659031
massimo.milani@difacooper.com
Sponsor type
Industry
Website
Funders
Funder type
Not defined
Funder name
Cantabria Labs Difa Cooper
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
25/04/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30404544 (added 28/04/2020)