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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28358282