Randomised, double-blind, multicentre clinical trial to evaluate the efficacy and safety of topical metformin in adjuvant to daylight photodynamic therapy in actinic keratoses.
This research is looking into a new way to treat actinic keratoses, a common rough or scaly spot on the skin caused by sun exposure. The study is for adults over 18 and will test a cream containing metformin alongside a standard light therapy called daylight photodynamic therapy. Researchers want to find out if applying this metformin cream makes the light treatment more effective at clearing up these skin lesions and how safe it is to use. Some participants will receive the metformin cream, while others will get a placebo cream (a cream without any active medicine) alongside the light treatment. The study will last for 12 weeks of treatment, followed by 36 weeks of observation to check how well the treatment works and if there are any side effects.
At a glance
What is this study about?
This study is investigating a new approach to treating a common skin condition called actinic keratoses. These are rough or scaly patches on your skin, typically found on areas that have been exposed to a lot of sun, like your face, ears, or hands. While they're usually harmless, some can turn into a type of skin cancer if not treated. Currently, one common way to treat them is using a special light therapy called daylight photodynamic therapy (daylight PDT).
In this study, researchers are exploring if adding a cream containing a medicine called metformin can improve how well daylight PDT works. Metformin is a drug usually used for diabetes, but scientists are now looking into its potential benefits for other conditions, including skin issues. The idea is to see if applying this cream before or with the light treatment can help clear up the actinic keratoses more effectively than daylight PDT alone.
This is an early-stage study, known as Phase II. This means it's one of the first times this specific combination (metformin cream with daylight PDT) is being tested in a larger group of people. The main goals are to check if this new cream is effective at treating actinic keratoses when used with light therapy and, importantly, to make sure it's safe for people to use.
Key takeaways
- This study is testing a new cream called metformin with a standard light treatment for actinic keratoses.
- It aims to see if the metformin cream makes the light treatment more effective and is safe.
- The study involves both treatment and observation periods, lasting almost a year in total.
- You won't know if you're getting the active metformin cream or a dummy cream.
- This is an early-stage study, exploring potential new treatment options.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
Before you can join, the doctors will check your general health and specifically look at your skin to make sure the study treatment is right for you. They will need to confirm that you have actinic keratoses and that these can be treated with topical (on the skin) treatments.
There might be other reasons why you can't join, such as if you are using certain other medications or have other medical conditions. The study team will go through all these details with you carefully to see if you're a good fit.
- Are you 18 years old or older?
- Do you have actinic keratoses that your doctor thinks can be treated with creams?
- Are you generally able to attend regular clinic appointments?
- Are you comfortable with the idea of receiving an active cream or a dummy cream?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll receive a cream (either the metformin cream or a cream without the active medicine, called a placebo) to use, along with standard daylight photodynamic therapy for 12 weeks. Neither you nor your study doctor will know which cream you are receiving. After these 12 weeks of treatment, the study team will then observe you for another 36 weeks to see how your skin responds and to check for any side effects. This means you'll have regular visits to the clinic over a total of about 48 weeks (just under a year) to monitor your progress. They will check your skin, ask about any changes you notice, and make sure you're doing well.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What are actinic keratoses?
They are rough, scaly patches on your skin, often caused by sun exposure. They are usually harmless but can sometimes turn into skin cancer.
What is 'daylight photodynamic therapy'?
It's a treatment where a special light-sensitive cream is applied to your skin, and then exposure to daylight activates the cream to treat the affected areas.
What is metformin?
Metformin is a medicine commonly used to treat diabetes, but researchers are now studying its potential uses for other conditions, including skin problems.
Will I know if I'm getting the actual metformin cream?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're receiving the metformin cream or a placebo cream. This helps ensure fair results.
How long will the study last for me?
Your involvement in the study will be for 12 weeks of treatment followed by an observation period of 36 weeks, for a total of about 48 weeks (just under a year).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.