Microwave Treatment for Actinic Keratosis

Trial Title: Microwave Treatment for Actinic Keratosis

NCT ID: NCT05636800

Condition: Keratosis, Actinic

Conditions: Official terms:
Keratosis, Actinic
Keratosis

Conditions: Keywords:
Actinic Keratosis
Swift System
Microwave
Keratosis
Solar Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
SCC

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Masking description: This is an open label study, however, there is a blinded site investigator at each site who will not be aware of the AK lesions that are randomized to treatment. The blinded site investigator will assess resolution and reoccurrence of the AK lesions. Photos of the AK lesions will be taken and these will be reviewed by three independent blinded assessors to assess cosmetic outcomes.

Intervention:

Intervention type: Device
Intervention name: Swift System
Description: Localized microwave energy applied to the distinct AK lesion. Each subject will receive treatment for a maximum of 2 visits (4-week interval between treatment). For AK lesions assessed as "Thin" AK (Olsen Grades 1 and 2): Set at 3W and apply locally for up to a 3 second burst and adjust the dose and duration. Repeat on the same AK lesion as is tolerable for the subject (3 repetitions). There will be approximately 20 seconds between each repeat dose. For AK lesions assessed as "Thick" AK (Olsen Grade 3): Set at 4W and apply locally for up to a 3 second burst and adjust the dose and duration. Repeat on the same AK lesion as is tolerable for the subject (3 repetitions). As the AK lesions may be larger than 3mm in diameter, the dose administered to one AK lesion may require overlapping applications with the applicator tip. Ensure there is approximately 20 seconds between each repeat dose administered
Arm group label: Microwave Treatment (Swift System)

Summary: This is a randomized, controlled, multi-center trial in subjects diagnosed with Actinic Keratosis (AK) where each subject serves as their own control. The trial will be conducted at 2 sites, one in Germany and one in the United States. Approximately 60 subjects will be randomized to ensure 51 subjects complete the study.

Detailed description: The primary objective of this trial is to evaluate the efficacy of the Swift Microwave Treatment on resolution of Actinic Keratosis lesions. The secondary objectives of this trial is to evaluate the efficacy, safety and tolerability of Swift Microwave treatment as a therapy for Actinic Keratosis (AK). Eligible subjects who provide written informed consent and have 10, 12 or 14 distinct Actinic Keratosis lesions located on their scalp or hands will be randomized onto the study. Randomization of AK lesions will be stratified by side. Subjects will be randomized to treatment on half the number of AK lesions mapped located on their scalp or hands. The mapped AK lesions not randomized for treatment will receive no treatment (control). The microwave energy applied by the Swift device will be applied to the randomized AK lesion sites for up to 2 treatments, spaced out by a 4-week interval. Follow-up is 2-months after the first treatment is administered where the AK lesions are assessed for resolution. Further follow-up visits occur at 4-months, 6-months and 12-months after the first treatment was administered where the AK lesions will be assessed for resolution or reoccurence.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age 18-85 years inclusive (EU); 22-85 years inclusive (US). 4. AK lesions for randomization in this study: Clinical diagnosis by a dermatologist of precancerous Actinic Keratosis. 5. Cutaneous location. 6. 10, 12 or 14 distinct AK lesions (3-6mm in diameter inclusive), for randomization in this study, located on the subjects' scalp or hands (AK lesions on the scalp and hands for randomization cannot be mixed). - There must be at least 2 AK lesions on the left and right side of the scalp or left and right hand. - An even number of distinct AK lesions (10, 12 or 14) are to be selected. - The maximum possible number of available distinct AK lesions should be selected (10, 12 or 14). - The subject may present with any number of AK lesions, however only 10, 12 or 14 distinct AK lesions will be selected for randomization. For example, if a subject presents with 21 AK lesions, an even number of distinct AK lesions are to be selected (i.e. 14 distinct AK lesions with at least 2 distinct AK lesions on the left and right side of the scalp or left and right hand). 7. If currently receiving treatment for Actinic Keratosis, agree to stop their current medication for at least 28 days prior to the start of study treatment. 8. Agrees to refrain from using any other Actinic Keratosis products or treatments during the study period, unless specified by the Investigator. 9. Agrees to refrain from using any topical metallic or ionic treatment (e.g., aluminum chloride, silver nitrate, zinc oxide) during the study period. 10. Free of any disease state or condition which, in the investigator's opinion, could impair evaluation of AK or could expose the subject to an unacceptable risk by study participation. 11. Able to perform study assessments. Exclusion Criteria: 1. AK lesions at potential treatment sites on lip, nose crease, near eyes or ear. 2. Confluent AK associated with field change at potential treatment sites. 3. Fewer than 2 AK lesions on the left and right side of the scalp or left and right hand. 4. AK lesions at potential treatment sites assessed as clinically ambiguous. 5. Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable electronic devices. 6. Metal implants at site of treatment. 7. Known allergy or intolerance to microwave therapy. 8. Unstable co-morbidities (cardiovascular disease, active malignancy, vasculopathy, inflammatory arthritis). 9. Previous history of skin cancer in the study treatment or observation area. 10. Previous history of squamous cell carcinoma (SCC) or keratoacanthoma (KA) in any location. 11. Pregnancy or breast feeding. 12. Participating in another interventional study or have done so within the last 30 days. 13. Anticipated relocation or extensive travel outside of the local study area preventing compliance with study procedures. 14. Circulatory conditions affecting the acral areas - peripheral vascular disease, peripheral ischemia, vasculitis, Raynaud's, or related conditions. 15. Peripheral neuropathy. 16. Subject who is immunosuppressed (organ transplant recipients, hematologic malignancies, HIV). 17. Subject who has had any topical metallic or ionic treatment (e.g, aluminum chloride, silver nitrate, zinc oxide) within the last 6 months at potential treatment sites. 18. 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.

Gender: All

Minimum age: 18 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: Miami Dermatology and Laser Institute

Address:
City: Miami
Zip: 33173
Country: United States

Facility:
Name: Centroderm GmbH

Address:
City: Wuppertal
Country: Germany

Start date: January 18, 2023

Completion date: November 1, 2024

Lead sponsor:
Agency: Blackwell Device Consulting
Agency class: Industry

Collaborator:
Agency: Emblation Limited
Agency class: Industry

Source: Blackwell Device Consulting

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05636800