Microwave Treatment for Actinic Keratosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2024-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Microwave Therapy for Treatment of Precancerous Actinic Keratoses

NCT03483935

Actinic Keratoses Precancerous Skin Lesion

COMPLETED NA

Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis

NCT01516515

Actinic Keratosis

COMPLETED PHASE2

Ph 1, Single-Center, Safety, Tolerability & Pharmacokinetic Study of KX2 391 Ointment in Subj. w Actinic Keratosis

NCT02337205

Actinic Keratosis

COMPLETED PHASE1

The Real Life Topical Field Treatment of Actinic Keratosis Study

NCT02362152

Actinic Keratosis

COMPLETED

Dose-finding, Safety, Efficacy Trial of Topical Resiquimod in Patients With Multiple Actinic Keratosis Lesions

NCT01583816

Actinic Keratosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Keratosis, Actinic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Microwave Treatment (Swift System)

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 Type EXPERIMENTAL

Swift System

Intervention Type DEVICE

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

No Treatment

No Treatment administered

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Swift System

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No