Condition category
Skin and Connective Tissue Diseases
Date applied
22/12/2016
Date assigned
23/12/2016
Last edited
31/03/2017
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-cancerous skin disease. It is more common in those with fair skin and long-term exposure to UV raditation from the sun is considered to be the main risk factor for its development. UV exposure is coinsidered the main risk factor. Dry scaly patches of skin (lesions) develop from years of sun exposure. These lesions are usually harmless and sometimes get better on their own, but they can be sore and itchy. In some cases, they can develop into skin cancer, which can have devastating consequences. Studies have shown that sun protection could reduce the risk of new AK lesions developing. The damage caused to the skin causes an increase cyclooxygenase (COX) 1 and 2 enzymes which are responsible for inflammation (swelling). Anti-COX drugs like diclofenac and piroxicam, applied to the skin, have shown to reduce the number of AK lesions. The aim of this study is to evaluate the efficacy of a skin cream containing sunscreen factors (50+) and piroxicam in the evolution of AK lesions.

Who can participate?
Adults with at least 3 or more AK lesion in sun exposed area

What does the study involve?
Participants are asked to apply the product twice daily in affected area for three months. At the start of the study and then again after three months, participants attend clinic visits at which the number and severity of their AK lesions are assessed.

What are the possible benefits and risks of participating?
The benefit for the patients in participating in the study is performing a sun-protection strategy for at least 3 months which could potentially prevent development of cancer. There are no otable risks involved with participating.

Where is the study run from?
1. Dr Mario Puviani Derma Plus Clinic (Italy)
2. Dr Sergio Pavove Dermatology Clinic (Italy)
3. Dr Galloni, Sant’Agostino Medical center (Italy)

When is the study starting and how long is it expected to run for?
June 2016 to December 2016

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

Scientific

Primary contact

Dr Massimo Milani

ORCID ID

http://orcid.org/0000-0001-7559-1202

Contact details

Difa Cooper SpA
Via Milano 160
Caronno Pertusella
21042
Italy
+39 (0)2965 9031
massimo.milani@difacooper.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ACT03/2016

Study information

Scientific title

Efficacy of a medical device containing sunscreen and piroxicam in the treatment of actinic keratosis: a multicenter assessor-blinded trial

Acronym

Study hypothesis

The aim of this study is to evaluate the clinical efficacy of a film-forming medical device with high sun protection factor (50+) and piroxicam, as first-line treatment in reducing actinic keratosis lesions in subject with actinic damage.

Ethics approval

Medi Plus Dermatological Clinic, 15/05/2015

Study design

Prospective interventional open assessor-blinded non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Actinic Keratosis

Intervention

All participants are aasked to apply the investigational drug (a cream) which contains chemical and physical sunscreen (SPF 50+) and piroxicam 0.8%, twice daily (morning and evening) to face and scalp for three consecutive months.

At baseline and after three months, participants undergo a clinical examination to assess the severity and total number of AK lesions.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Total lesion number of Actinic Keratosis is assessed with a clinical count at baseline and 3 months
2. Dermatoscopy score of target lesion evolution (scoring erythema, scaling, pigmentation, follicular plug) at baseline and 3 months

Secondary outcome measures

1. Severity index of AK lesions is assessed through clinical evaluation by the investigator at baseline and 3 months
2. Investigator Global Index is assessed through clinical evaluation by the investigator at baseline and 3 months

Overall trial start date

01/06/2016

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. At least 3 or more actinic keratosis lesions in a 35 cm2 area
2. Age >18 years
3. Fitzpatrick Phototype <III

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Previous treatments for Actinic Keratosis
2. Presence of Non melanoma skin cancer
3. HIV infection or other immunodepression diseases
4. Allergy to piroxicam
5. Pregnancy or breastfeeding

Recruitment start date

15/06/2016

Recruitment end date

01/09/2016

Locations

Countries of recruitment

Italy

Trial participating centre

Dr Mario Puviani Derma Plus Clinic
Via GL Bernini
Modena
41121
Italy

Trial participating centre

Sergio Pavone Dermatology Clinic
Santanna Hospital
Como
20100
Italy

Trial participating centre

Dr Galloni, Sant’Agostino Medical center
Sant’agostino Place
Milan
20126
Italy

Sponsor information

Organisation

Difa Cooper SpA

Sponsor details

Via Milano 160
Caronno Pertusella (VA)
21042
Italy

Sponsor type

Industry

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

The intention is to publish the resualt in a Pub-med indexed scientific journal.

IPD Sharing plan:
The repository is an Excel file reporting clinical data and outcome data. Participants are coded with progressive numbers in an anonymous form. All participants signed an informed consent prior the enrolment in the trial.

Intention to publish date

03/03/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28358282

Publication citations

Additional files

Editorial Notes

31/03/2017: Publication reference added.