Active not recruitingNAINTERVENTIONAL

Microwave Treatment for Actinic Keratosis

This study is testing a new microwave treatment called 'Swift System' for common skin patches called Actinic Keratosis (AK), which can sometimes turn into skin cancer. The aim is to find out if this microwave treatment can make these patches disappear and if it's safe for people to use. Around 60 people who have AK on their scalp or hands will take part. If you join, some of your AK patches will be treated with the Swift microwave device, while others won't be treated at all. This helps the researchers compare the results directly on your skin. You'll have two treatments about a month apart and then follow-up checks for up to a year to see how well the treatment worked and if the AKs come back.

At a glance

Status

Active not recruiting

Phase

Sponsor

Blackwell Device Consulting

Enrolment target

Start

18 Jan 2023

Estimated completion

01 Nov 2024

Keratosis, Actinic

What is this study about?

Actinic keratosis (AK) are common, rough, scaly patches that develop on skin that has been exposed to the sun for a long time, like the face, scalp, and hands. While they are not usually harmful, they can sometimes develop into a type of skin cancer if left untreated. Because of this, doctors often recommend treating them.

This study is looking at a new way to treat AK using a device called the 'Swift System,' which uses microwave energy. The main goal of this research is to see how good this microwave treatment is at making AK patches disappear. Researchers also want to check if it's safe to use and if people can tolerate the treatment well.

By taking part, you would help doctors understand if this new microwave treatment could be a good option for people with AK in the future. The study is particularly interested in AKs located on the scalp and hands.

Key takeaways

This study is testing a new microwave treatment for actinic keratosis (AK).
It aims to see how well the treatment clears AKs and if it's safe.
People with AK on their scalp or hands are being recruited.
Some of your AKs will be treated, others will not, for direct comparison.
Involves two treatment sessions and follow-up for up to one year.

Who may be eligible?

To join this study, you need to be an adult between 18 and 85 years old (or 22-85 in the US). You must have a diagnosis of actinic keratosis (AK) from a skin doctor, and specifically have 10, 12, or 14 distinct AK patches on either your scalp or your hands (not mixed).

It's important that you are willing to follow all the study instructions and attend all appointments. If you're currently using other treatments for your AK, you'd need to stop them for at least 28 days before starting this study. Also, you'd need to agree not to use other AK treatments or certain skin products on the treatment area during the study.

The study team will also check to make sure you don't have any other health conditions that would make it unsafe for you to participate or make it hard to accurately check your AK.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Have you been diagnosed with actinic keratosis by a dermatologist?
Do you have exactly 10, 12, or 14 AK patches on either your scalp or hands?
Are you able to stop other AK treatments and specific skin products during the study?
Are you willing to attend all study appointments for up to a year?

Answer every question to see your result.

What does participation involve?

If you decide to join the study, you will first sign a consent form and confirm you understand what's involved. The researchers will then pick 10, 12, or 14 specific AK patches on your scalp or hands for the study. About half of these chosen AK patches will be given the microwave treatment, while the other half will not be treated, acting as a comparison.

You will have two treatment sessions, with about a month (4 weeks) between them. After your first treatment, you'll have follow-up visits with the study team. The first check-up will be 2 months after your initial treatment. Further visits will happen at 4 months, 6 months, and 12 months after the first treatment. During these visits, the researchers will check your AK patches to see if they have cleared up or if any have returned.

Potential risks and benefits

Taking part in this study may offer a potential benefit if the microwave treatment helps clear your actinic keratosis patches. For those patches that receive no treatment, their natural course will be observed. As with any medical procedure, there could be risks or side effects from the microwave treatment, though these are not detailed here. You will be fully informed of any known risks during the consent process. Remember, joining any study is completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Miami Dermatology and Laser Institute
Verified postcode
Miami, United States
Centroderm GmbH
Verified postcode
Wuppertal, Germany

Common questions

What is actinic keratosis (AK)?

AKs are common, rough skin patches caused by sun exposure. They are often found on the scalp, face, or hands and can sometimes turn into skin cancer.

What is the 'Swift System' treatment?

The Swift System is a device that uses microwave energy to treat certain skin conditions, and this study is testing it for actinic keratosis.

Will all my AKs be treated if I join?

No, if you have 10, 12, or 14 AKs chosen for the study, only about half of them will receive the microwave treatment. The others will be left untreated for comparison.

How long does the study last?

You'll have two treatments over about a month, and then follow-up visits will continue for up to 12 months (one year) after your first treatment.

Can I use other AK treatments during the study?

Generally no, you'll need to stop other AK treatments before the study and avoid them, as well as certain skin products, throughout the study period, unless your study doctor says otherwise.