Efficacy of a sunscreen containing the anti-iflammatory piroxicam in the treatment of early skin cancer

ISRCTN ISRCTN22070974
DOI https://doi.org/10.1186/ISRCTN22070974
Secondary identifying numbers ACT-03-2016
Submission date
19/04/2019
Registration date
30/04/2019
Last edited
05/12/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Massimo Milani
Public

Via Milano 160
Caronno Pertusella
21042
Italy

ORCiD logoORCID ID 0000-0001-7559-1202
Phone +39029659031
Email massimo.milani@difacooper.com

Study information

Study designProspective assessor-blinded trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available
Scientific titleEffects 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
Study objectivesTo 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(s)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
Health condition(s) or problem(s) studiedActinic keratosis, in situ skin carcinoma
InterventionA 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 typeDevice
Pharmaceutical study type(s)
PhasePhase III/IV
Drug / device / biological / vaccine name(s)Actixicam MD
Primary outcome measureClinical 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 measures1. 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 study start date01/04/2016
Completion date01/04/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants54
Total final enrolment54
Key inclusion criteria1. Aged 18 or above
2.Presence of multiple AK lesions on the face or scalp
Key exclusion criteria1. 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.
Date of first enrolment01/09/2016
Date of final enrolment01/12/2017

Locations

Countries of recruitment

  • Italy

Study participating centres

Dermatological Clinic Federico II University of Naples
Via Pansini 5
Naples
00200
Italy
Dermatology Clinic Tor Vergata University Rome
Viale Oxford 81
Rome
00100
Italy

Sponsor information

Difa Cooper
Not defined

Via Milano 160
Caronno Pertusella
21042
Italy

Phone +39029659031
Email massimo.milani@difacooper.com
Website difacooper.com
ROR logo "ROR" https://ror.org/044sr7e96

Funders

Funder type

Industry

Difa Cooper

No information available

Results and Publications

Intention to publish date01/06/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planWe would like to publish the results of this study in a peer-reviewed international scientific journal
IPD sharing planThe 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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2019 05/12/2019 Yes No

Editorial Notes

05/12/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
27/08/2019: Internal review.
03/05/2019: Internal review.