Efficacy of Actixicam, a sunscreen with piroxicam, in actinic keratosis
| ISRCTN | ISRCTN72020277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72020277 |
| Protocol serial number | ACT03/2016 |
| Sponsor | Difa Cooper SpA |
| Funder | Difa Cooper |
- 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
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
Scientific
Difa Cooper SpA
Via Milano 160
Caronno Pertusella
21042
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|---|
| Phone | +39 (0)2965 9031 |
| massimo.milani@difacooper.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective interventional open assessor-blinded non randomised study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Efficacy of a medical device containing sunscreen and piroxicam in the treatment of actinic keratosis: a multicenter assessor-blinded trial |
| Study objectives | 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(s) | Medi Plus Dermatological Clinic, 15/05/2015 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Total lesion number of Actinic Keratosis is assessed with a clinical count at baseline and 3 months |
| Key secondary outcome measure(s) |
1. Severity index of AK lesions is assessed through clinical evaluation by the investigator at baseline and 3 months |
| Completion date | 01/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. At least 3 or more actinic keratosis lesions in a 35 cm2 area 2. Age >18 years 3. Fitzpatrick Phototype <III |
| Key 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 |
| Date of first enrolment | 15/06/2016 |
| Date of final enrolment | 01/09/2016 |
Locations
Countries of recruitment
- Italy
Study participating centres
Modena
41121
Italy
Como
20100
Italy
Milan
20126
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/03/2017: Publication reference added.
