Condition category
Skin and Connective Tissue Diseases
Date applied
07/05/2018
Date assigned
21/05/2018
Last edited
15/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

Publication citations

Additional files

Editorial Notes