Condition category
Skin and Connective Tissue Diseases
Date applied
19/04/2019
Date assigned
30/04/2019
Last edited
03/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

difacooper.com

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)

AK lesions significantly decreased to 5.9 and to 5.6 after 3 and 6 months of ACTX treatment (P=0.001; Intention to treat analysis), representing a -42% reduction. A reduction of AK lesion number >50% in comparison with baseline was observed in 51% of subjects at month 6. New AK lesions appeared in 5 subjects (9%).

Publication list

Publication citations

Additional files

Editorial Notes

03/05/2019: Internal review.