Microwave Treatment for Actinic Keratosis

Not currently recruiting at 1 trial location

Overseen By Professor Dirschka

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Blackwell Device Consulting

Disqualifiers: Unstable comorbidities, Skin cancer history, Immunosuppressed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new microwave treatment using the Swift System to address Actinic Keratosis (AK), a skin condition that can lead to cancer. The researchers aim to assess the treatment's effectiveness by comparing treated and untreated AK spots on the same person. Participants must have 10, 12, or 14 small AK lesions (pre-cancerous skin patches) on their scalp or hands. Those with these conditions who are willing to pause any current treatments for AK may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new treatment options for AK.

Will I have to stop taking my current medications?

If you are currently receiving treatment for Actinic Keratosis, you will need to stop your medication for at least 28 days before starting the study treatment. You also need to avoid using any other Actinic Keratosis products or treatments during the study.

What prior data suggests that this microwave treatment is safe for actinic keratosis?

Research has shown that microwave therapy, such as the Swift System, is generally safe and well-tolerated for treating actinic keratosis (AK). Studies have found this therapy easy to use and acceptable for treating AK, making it a promising option to prevent the condition from worsening. Reports indicate that this therapy is both safe and effective.

Although specific data on side effects for this treatment is limited, using microwave therapy for similar skin conditions suggests it is likely well-tolerated. The treatment involves short bursts of microwave energy applied directly to the affected area, so any discomfort is usually brief.

Overall, while more data would be helpful, existing studies suggest that the Swift System is a safe option for treating AK. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Microwave treatment with the Swift System is unique because it uses microwave energy to target actinic keratosis lesions directly. Unlike traditional treatments like topical creams or cryotherapy, which can take time to show results, this method delivers a quick burst of energy directly to the lesion, potentially offering faster and more precise results. Researchers are excited about its non-invasive approach and the possibility of fewer side effects, making it a promising alternative for managing actinic keratosis.

What evidence suggests that the Swift System is effective for Actinic Keratosis?

Research has shown that the Swift System, a microwave treatment, may effectively treat Actinic Keratosis (AK), a skin condition. One study found that 90% of AK spots disappeared 120 days after the microwave treatment. Remarkably, 78% of spots cleared up just one week after treatment. This trial will evaluate the effectiveness of the Swift System, with participants receiving microwave treatment applied locally to each AK lesion. The early results are promising, making it a potential option for people with AK. ^{1 2 3 6 7}

Who Is on the Research Team?

Professor Dirschka

Principal Investigator

CentroDerm GmbH, Heinz-Fangman-Strasse 57, 42287 Wuppertal (Barmen), Germany

Dr Waibel

Principal Investigator

Miami Dermatology and Laser Institute, Miami, Florida, United States, 33173

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Provision of signed and dated informed consent form

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

Exclusion Criteria

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

I haven't used any metallic or ionic treatments like aluminum or zinc on my skin in the last 6 months.

Participating in another interventional study or have done so within the last 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Swift Microwave Treatment for Actinic Keratosis lesions, with up to 2 treatments spaced by a 4-week interval

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for resolution or recurrence of AK lesions at 2, 4, 6, and 12 months post first treatment

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Swift System

Trial Overview 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.

How Is the Trial Designed?

Group I: Microwave Treatment (Swift System) Experimental Treatment 1 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 Treatment Active Control 1 Intervention

No Treatment administered

Who Is Running the Clinical Trial?

Blackwell Device Consulting

Lead Sponsor

Trials

2

Recruited

180+

Emblation Limited

Industry Sponsor

Trials

4

Recruited

240+

Published Research Related to This Trial

In a study involving 12 patients with multiple actinic keratoses (AKs), a sequential treatment using Solaraze gel followed by Actikerall solution achieved complete clearance in 8 out of 10 male patients and all female patients, demonstrating high efficacy for treating AKs.

The treatment was well tolerated, with only minor side effects such as contact dermatitis in one case, indicating a favorable safety profile and significant improvement in patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential treatment of multiple actinic keratoses with solaraze and actikerall. Dirschka, T., Lear, JT.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7496712/

A feasibility study of microwave therapy for precancerous ... This first‐in‐human study suggests that microwave therapy might be a promising treatment for AK, with 90% of AKs showing resolution of the treated area at 120 ...

2. clinicaltrial.be clinicaltrial.be/en/details/189384?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Microwave Treatment for Actinic Keratosis - Clinical Tria... The primary objective of this trial is to evaluate the efficacy of the Swift Microwave Treatment on resolution of Actinic Keratosis lesions.

3. emblation.com emblation.com/treating-actinic-keratosis-using-swift-microwave-therapy/

Treating Actinic Keratosis using Swift microwave therapy 90% of treated AKs resolved 120 days post treatment, with 78% resolving after one week. The early findings in this small cohort of patients delivered promising ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03483935

Microwave Therapy for Treatment of Precancerous Actinic ... This is a two-stage feasibility study to determine if focussed microwave energy is a suitable treatment for Actinic Keratoses (AK).

5. withpower.com withpower.com/trial/phase-keratosis-actinic-10-2022-8e4bb

Microwave Treatment for Actinic Keratosis 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 ...

6. academic.oup.com academic.oup.com/skinhd/article/4/6/ski2.455/7950877

Safety and Efficacy of the Swift Microwave Device in Patients ... This study will be the first to report on the safety and efficacy of microwave treatment in onychomycosis patients in a trial setting; recruitment is ongoing.

7. emblation.com emblation.com/swift-system-shows-significant-potential-to-offer-efficient-treatment-of-actinic-keratosis/

Swift System Shows “Significant Potential to Offer Efficient ... "Removing these lesions can offer protection against more serious skin diseases including some forms of cancer, and an effective treatment that ...