Plain English Summary
Background and study aims
Actinic keratosis is a early phase of a skin tumor caused by excessive sun exposure. It is known that during AK there is an increase activity of specific enzymes called ciclo-oxygenase (COX1 and COX 2) and this hyperactivity could promote the growth of cancer cells of the skin. Piroxicam is an inhibitor of COX1 and COX 2. Therefore the topical application of piroxicam on the skin with AK could be beneficial in term of reduction of the evolution of the cancer lesion. In this study we want to evaluate the efficacy of a particular sunscreen cream containing piroxicam (an anti-inflammatory agent) in order to treat actinic keratosis lesions on the face. In this trial we also want to evaluate the tumor lesions with a specific high resolution microscope (Reflectance Confocal Microscope) and with dermoscopy.
Who can participate?
Anyone aged over 18, who has multiple actinic keratosis lesions can participate in the study.
What does the study involve?
The study involves subjects with actinic keratosis which are pre-malignant skin lesions due to excessive sun exposure
What are the possible benefits and risks of participating?
The potential benefit for participating subjects is related to the possibility to reduce the evolution of these premalignant skin lesions following the application of a cream with sunscreen action and in addition containing a substance (piroxicam) which could have an anti-inflammatory and anti-tumor actions. No particular risks for the participating subjects are forecasted due to the good safety and tolerability profile of the product which has been used in more than ten thousand subjects so far.
Where is the study run from?
1. Dermatological Clinic Federico II University of Naples, Italy
2. Dermatology Clinic Tor Vergata University Rome, Italy
When is the study starting and how long is it expected to run for?
September 2016 to December 2017
Who is funding the study?
Difa Cooper, Italy
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
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
ACT-03-2016
Study information
Scientific title
Effects of topical piroxicam and sun filters in actinic keratosis evolution and field cancerization: a two-center, assessor-blinded, clinical, confocal microscopy and dermoscopy evaluation trial
Acronym
Study hypothesis
To evaluate in a two-center, prospective trial the effect of a piroxicam-based sunscreen on the evolution of Actinic Keratosis (AK) number, and on confocal microscopy and dermoscopy parameters evolution of a target lesion in subjects with multiple AK lesions.
Ethics approval
Approved 20/07/2016, IRB University of Tor Vergata (Ethical committee Università Tor Vergata Viale Oxford 81, Rome, Italy; etico@ptvonline.it) ref: 116/16
Study design
Prospective assessor-blinded trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available
Condition
Actinic keratosis, in situ skin carcinoma
Intervention
A Piroxicam-based sunscreen 50+
The intervention involves the application of the evaluated cream twice daily on the target area, using one Finger-Tip-Unit (0.5 g) for the treatment of at least a 35 cm2 area for 6 consecutive months. The study did not include a follow-up evaluation period
Intervention type
Device
Phase
Phase III/IV
Drug names
Actixicam MD
Primary outcome measure
Clinical evolution of AK lesions number on a target zone area defined as the area with the highest number of AK lesions. Lesion count was assessed with an assessor-blinded approach evaluating digital color high definition images performed at each visit and coded in a blinded fashion at baseline, month 3 (week 12) and month 6 (week 24).
Secondary outcome measures
1. Reflectance confocal microscopy (RCM) calculated assessing 11-item with examination of stratum corneum, granular, spinous and derma layers: Disruption of keratinocytes, Parakeratosis, Polygonal keratinocytes, atypical honeycomb, inflammatory cells, round nucleated cells, curled fibers, collagen alteration, increased vascularity, dermal inflammation, melanophages) at baseline, month 3 (week 12) and month 6 (week 24).
2. Dermoscopy score (DS) features of the target lesion performed assessing erythema, scaling, pigmentation, and follicular plug, using a 5-point score (from 0 to 4 for each item; maximum score: 16) at baseline and month 6 (week 24).
Overall trial start date
01/04/2016
Overall trial end date
01/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 or above
2.Presence of multiple AK lesions on the face or scalp
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
54
Total final enrolment
54
Participant exclusion criteria
1. Recently received previous treatments interfering with the evaluation of the treatment area (topical medications, immunosuppressive or immunomodulating agents, phototherapy, oral retinoids, or other therapies for AKs).
2. Pregnant or breast-feeding.
Recruitment start date
01/09/2016
Recruitment end date
01/12/2017
Locations
Countries of recruitment
Italy
Trial participating centre
Dermatological Clinic Federico II University of Naples
Via Pansini 5
Naples
00200
Italy
Trial participating centre
Dermatology Clinic Tor Vergata University Rome
Viale Oxford 81
Rome
00100
Italy
Sponsor information
Organisation
Difa Cooper
Sponsor details
Via Milano 160
Caronno Pertusella
21042
Italy
+39029659031
massimo.milani@difacooper.com
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
Difa Cooper
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We would like to publish the results of this study in a peer-reviewed international scientific journal
IPD sharing statement:
The datasets generated during and analysed during the current study will be available upon request from Dr Massimo Milani; Massimo.milani@difacooper.com
Type of data: Excel database and GraphPad datasheet
What types of analyses: Descriptive and inferential statistics
Written informed consent was obtained from participants was obtained
Intention to publish date
01/06/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31148490 (added 05/12/2019)