Efficacy of Actixicam, a sunscreen with piroxicam, in actinic keratosis

ISRCTN ISRCTN72020277
DOI https://doi.org/10.1186/ISRCTN72020277
Secondary identifying numbers ACT03/2016
Submission date
22/12/2016
Registration date
23/12/2016
Last edited
31/03/2017
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 (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

Contact information

Dr Massimo Milani
Scientific

Difa Cooper SpA
Via Milano 160
Caronno Pertusella
21042
Italy

ORCiD logoORCID ID 0000-0001-7559-1202
Phone +39 (0)2965 9031
Email massimo.milani@difacooper.com

Study information

Study designProspective interventional open assessor-blinded non randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Community
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEfficacy of a medical device containing sunscreen and piroxicam in the treatment of actinic keratosis: a multicenter assessor-blinded trial
Study objectivesThe 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(s)Medi Plus Dermatological Clinic, 15/05/2015
Health condition(s) or problem(s) studiedActinic Keratosis
InterventionAll 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure1. 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 measures1. 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 study start date01/06/2016
Completion date01/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. At least 3 or more actinic keratosis lesions in a 35 cm2 area
2. Age >18 years
3. Fitzpatrick Phototype <III
Key exclusion criteria1. 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
Date of first enrolment15/06/2016
Date of final enrolment01/09/2016

Locations

Countries of recruitment

  • Italy

Study participating centres

Dr Mario Puviani Derma Plus Clinic
Via GL Bernini
Modena
41121
Italy
Sergio Pavone Dermatology Clinic
Santanna Hospital
Como
20100
Italy
Dr Galloni, Sant’Agostino Medical center
Sant’agostino Place
Milan
20126
Italy

Sponsor information

Difa Cooper SpA
Industry

Via Milano 160
Caronno Pertusella (VA)
21042
Italy

ROR logo "ROR" https://ror.org/044sr7e96

Funders

Funder type

Industry

Difa Cooper

No information available

Results and Publications

Intention to publish date03/03/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planThe intention is to publish the resualt in a Pub-med indexed scientific journal.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2017 Yes No

Editorial Notes

31/03/2017: Publication reference added.