Microwave Treatment for Actinic Keratosis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byProfessor Dirschka

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Blackwell Device Consulting

No Placebo Group

Trial Summary

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.

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.

+11 more

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

+15 more

Participant Groups

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.

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