Microwave Treatment for Actinic Keratosis

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

60 Participants Needed

Trial Summary

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.

How does the microwave treatment for actinic keratosis differ from other treatments?

The microwave treatment for actinic keratosis is unique because it uses microwave energy, which is a method already established in treating certain cancers and plantar warts, to target and treat the skin lesions. This approach is different from traditional treatments like photodynamic therapy or topical creams, which often involve chemical agents or light activation. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

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

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A feasibility study of microwave therapy for precancerous actinic keratosis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

ALA/PDT in the treatment of actinic keratosis: spot versus confluent therapy. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Sequential treatment of multiple actinic keratoses with solaraze and actikerall. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Levulan: the first approved topical photosensitizer for the treatment of actinic keratosis. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Non-ablative fractional resurfacing in combination with topical tretinoin cream as a field treatment modality for multiple actinic keratosis: a pilot study and a review of other field treatment modalities. [2018]