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Microwave Treatment for Actinic Keratosis
Study Summary
This trial will compare a treatment for Actinic Keratosis, where each subject acts as their own control, in two different countries. 60 people will be studied, with 51 completing the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have AK on my scalp and cannot or will not remove my hearing aids for microwave treatment.I have at least 2 AK lesions on both sides of my scalp or hands.I haven't used any metallic or ionic treatments like aluminum or zinc on my skin in the last 6 months.I agree not to use any Actinic Keratosis treatments not approved by the study.I agree to stop my Actinic Keratosis medication 28 days before the study starts.You need to have an even number of specific skin lesions (10, 12, or 14) for the study.My skin lesions are unclear and might be actinic keratosis.I can participate in all required study check-ups and tests.You are allergic or intolerant to microwave therapy.I have widespread skin damage in areas that might be treated.I have less than 2 AK lesions on each side of my scalp or hands.I have 10 to 14 AK lesions on either my scalp or hands, not both.I have had squamous cell carcinoma or keratoacanthoma before.I have a weakened immune system due to conditions like organ transplant, blood cancer, or HIV.I have a blood circulation condition affecting my hands or feet.I don't have any health conditions that would risk my safety in the study.You have metal implants where the treatment will be done.I do not have unstable heart disease, cancer, blood vessel issues, or severe joint inflammation.I am between 18-85 years old (EU) or 22-85 years old (US).I am willing and able to follow all study rules and attend all appointments.I have nerve damage in my hands or feet.My cancer is located on the skin.I agree not to use any metallic or ionic skin treatments during the study.I have been diagnosed with precancerous Actinic Keratosis by a dermatologist.You should have a certain number of distinct AK lesions available for selection.You have a device like a pacemaker or defibrillator implanted in your body.I have had skin cancer in the area being studied or observed.I have skin lesions near my lips, nose, eyes, or ears.
- Group 1: Microwave Treatment (Swift System)
- Group 2: No Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the age range for trial participants broadened to incorporate individuals 45 years and older?
"According to the study parameters, only those 18-85 years old can join this trial. 2 spots are designated for minors and 25 openings have been made available for people aged 65 or more."
Could I potentially qualify for this research project?
"In order to be eligible for this study, potential participants must have actinic keratosis and should range between 18-85 years old. The program is looking to accept 60 candidates in total."
Is enrollment for this trial ongoing?
"Indeed, the clinical trial is actively recruiting as per information available on clinicaltrials.gov. This medical experiment was first announced on January 18th 2023 and has since been modified in content or structure most recently on January 19th of the same year."
What is the current participation rate of this medical experiment?
"Affirmative. As indicated by information on clinicaltrials.gov, this medical research is currently recruiting test subjects. The trial was first posted in January of 18th 2023 and the last update was made a day later; there are 60 patients that need to be recruited from one site."
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