Efficacy of different photoprotection strategies in preventing actinic keratosis recurrence after photodynamic therapy
| ISRCTN | ISRCTN16168548 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16168548 |
| Secondary identifying numbers | ACTX-01-2017 |
- Submission date
- 07/05/2018
- Registration date
- 21/05/2018
- Last edited
- 28/04/2020
- 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 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
Contact information
Public
Via Milano 160
Caronno Pertusella
21042
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|---|
| Phone | +39029659031 |
| massimo.milani@difacooper.com |
Study information
| Study design | Pragmatic randomized open-label assessor-masked trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study acronym | ATHENA |
| Study objectives | 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(s) | IRB Dermolaser Clinic, Verona, Italy, 15/01/2017, RS: 01-DLC-17 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2016 |
| Completion date | 25/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 64 evaluable subject |
| Total final enrolment | 68 |
| Key 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) |
| Key exclusion criteria | 1. Other acute skin diseases other than AK 2. Known allergy to one of the components of products used in the trial |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 30/09/2017 |
Locations
Countries of recruitment
- Italy
Study participating centres
Erba-Rinaldi Hospital
Via Casartelli Menaggio
Menaggio
20126
Italy
Verona
10090
Italy
Sponsor information
Industry
Via Milano 160
Caronno Pertusella
21042
Italy
| Phone | +39029659031 |
|---|---|
| massimo.milani@difacooper.com | |
"ROR" |
https://ror.org/044sr7e96 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 25/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2019 | 28/04/2020 | Yes | No |
Editorial Notes
28/04/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
