What is the mechanism of action of this treatment?

Actinic Keratosis (AK) is commonly treated with topical agents like 5-fluorouracil, which inhibits DNA synthesis in rapidly dividing cells, leading to cell death. This is crucial for AK patients because it targets the abnormal keratinocytes that proliferate due to UV damage, thereby preventing progression to squamous cell carcinoma. Other treatments, such as imiquimod, stimulate the immune system to attack abnormal cells, and photodynamic therapy uses light-activated compounds to destroy precancerous cells. These mechanisms are vital as they directly address the cellular abnormalities in AK, reducing the risk of skin cancer development.

What side effects are associated with this type of intervention?

Common treatments for Actinic Keratosis, such as topical 5-Fluorouracil, often cause local skin reactions including redness, irritation, burning, and inflammation. Patients may also experience peeling, crusting, and discomfort at the application site. These side effects are typically temporary and subside after the treatment course is completed. In some cases, more severe reactions like ulceration or infection can occur, necessitating medical attention.

What prior FDA approvals exist?

Topical 5-Fluorouracil (5-FU) is an FDA-approved treatment for Actinic Keratosis, working by inhibiting DNA synthesis in rapidly dividing cells, leading to cell death. Other FDA-approved topical treatments for AK include Imiquimod, which stimulates the immune system to attack abnormal cells, and Ingenol Mebutate, which induces cell death and promotes an immune response. These treatments are effective in managing AK by targeting and eliminating precancerous cells.

What other types of research exist?

Promising, novel alternatives to Topical 5-Fluorouracil for Actinic Keratosis patients include microwave treatment and photodynamic therapy (PDT).

← Back to Search

Microwave Therapy

Microwave Treatment for Actinic Keratosis

N/A

Waitlist Available

Led By Professor Dirschka

Research Sponsored by Blackwell Device Consulting

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

There must be at least 2 AK lesions on the left and right side of the scalp or left and right hand

Agrees to refrain from using any other Actinic Keratosis products or treatments during the study period, unless specified by the Investigator

Must not have

Subjects with AK on the scalp and who have hearing aid(s) and are unable or unwilling to remove hearing aids prior to microwave treatment

Confluent AK associated with field change at potential treatment sites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 4 and 6 months post first treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new microwave treatment for people with Actinic Keratosis, a type of skin lesion. The treatment uses microwaves to heat and remove the abnormal skin cells. The study aims to see if this method is effective and safe. Microwave therapy is an established cancer treatment and has been used for plantar viral warts.

Who is the study for?

This trial is for adults with Actinic Keratosis lesions on their scalp or hands. Participants must have an even number of lesions (10, 12, or 14) and agree not to use other AK treatments during the study. Exclusions include pregnancy, breastfeeding, recent participation in another trial, certain medical conditions like skin cancer history or immunosuppression, and metal implants at treatment sites.

What is being tested?

The Swift System microwave treatment for Actinic Keratosis is being tested. Each participant serves as their own control in this randomized study across two sites—one in Germany and one in the U.S.—aiming for 51 completions from about 60 participants.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include discomfort at the treatment site, skin reactions such as redness or swelling, and possible allergic reactions to microwave therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have at least 2 AK lesions on both sides of my scalp or hands.

Select...

I agree not to use any Actinic Keratosis treatments not approved by the study.

Select...

I have 10 to 14 AK lesions on either my scalp or hands, not both.

Select...

I am between 18-85 years old (EU) or 22-85 years old (US).

Select...

I agree not to use any metallic or ionic skin treatments during the study.

Select...

I have been diagnosed with precancerous Actinic Keratosis by a dermatologist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have AK on my scalp and cannot or will not remove my hearing aids for microwave treatment.

Select...

I have widespread skin damage in areas that might be treated.

Select...

I have less than 2 AK lesions on each side of my scalp or hands.

Select...

I have had squamous cell carcinoma or keratoacanthoma before.

Select...

I have a weakened immune system due to conditions like organ transplant, blood cancer, or HIV.

Select...

I have a blood circulation condition affecting my hands or feet.

Select...

I do not have unstable heart disease, cancer, blood vessel issues, or severe joint inflammation.

Select...

I have nerve damage in my hands or feet.

Select...

I have had skin cancer in the area being studied or observed.

Select...

I have skin lesions near my lips, nose, eyes, or ears.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 4 and 6 months post first treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 4 and 6 months post first treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 4 and 6 months post first treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment.

Secondary study objectives

Difference in cosmetic outcomes between treated and non-treated Actinic Keratosis as classified by the independent blinded assessors using a grading system

Duration of pain after treatment using a time period scale

Evaluation of Cosmetic Outcome at 6 months post first treatment using a rating scale

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Microwave Treatment (Swift System)Experimental Treatment1 Intervention

3-4 Watts applied locally for up to a 3 second burst to each AK lesion, repeated 3 times per lesion. Burst is defined as a single delivery of microwave energy. There will be approximately 20 seconds between each repeat dose.

Group II: No TreatmentActive Control1 Intervention

No Treatment administered

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Actinic Keratosis (AK) is commonly treated with topical agents like 5-fluorouracil, which inhibits DNA synthesis in rapidly dividing cells, leading to cell death. This is crucial for AK patients because it targets the abnormal keratinocytes that proliferate due to UV damage, thereby preventing progression to squamous cell carcinoma. Other treatments, such as imiquimod, stimulate the immune system to attack abnormal cells, and photodynamic therapy uses light-activated compounds to destroy precancerous cells. These mechanisms are vital as they directly address the cellular abnormalities in AK, reducing the risk of skin cancer development.

Randomized, vehicle-controlled trials of topical 5-fluorouracil therapy for actinic keratosis treatment: an overview.