Keratosis, ActinicNCT05636800
Microwave Treatment for Actinic Keratosis
A study testing Swift System in people with Keratosis, Actinic, run by Blackwell Device Consulting at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Keratosis, Actinic
- What is being tested?
- Swift System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Jan 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age 18-85 years inclusive (EU); 22-85 years inclusive (US).
- AK lesions for randomization in this study: Clinical diagnosis by a dermatologist of precancerous Actinic Keratosis.
- Cutaneous location.
- 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).
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- 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).
- 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.
- Agrees to refrain from using any other Actinic Keratosis products or treatments during the study period, unless specified by the Investigator.
- Agrees to refrain from using any topical metallic or ionic treatment (e.g., aluminum chloride, silver nitrate, zinc oxide) during the study period.
- 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.
- Able to perform study assessments.
Who cannot join
- AK lesions at potential treatment sites on lip, nose crease, near eyes or ear.
- Confluent AK associated with field change at potential treatment sites.
- Fewer than 2 AK lesions on the left and right side of the scalp or left and right hand.
- AK lesions at potential treatment sites assessed as clinically ambiguous.
- Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable electronic devices.
- Metal implants at site of treatment.
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- Known allergy or intolerance to microwave therapy.
- Unstable co-morbidities (cardiovascular disease, active malignancy, vasculopathy, inflammatory arthritis).
- Previous history of skin cancer in the study treatment or observation area.
- Previous history of squamous cell carcinoma (SCC) or keratoacanthoma (KA) in any location.
- Pregnancy or breast feeding.
- Participating in another interventional study or have done so within the last 30 days.
- Anticipated relocation or extensive travel outside of the local study area preventing compliance with study procedures.
- Circulatory conditions affecting the acral areas - peripheral vascular disease, peripheral ischemia, vasculitis, Raynaud's, or related conditions.
- Peripheral neuropathy.
- Subject who is immunosuppressed (organ transplant recipients, hematologic malignancies, HIV).
- 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.
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Miami Dermatology and Laser Institute
Miami, Florida, 33173
About this study
Official title: Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment for Actinic Keratosis
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.
Read the 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.
- Conditions
- Keratosis, Actinic
- Being tested
- Swift System
- Keywords
- Actinic Keratosis, Swift System, Microwave, Keratosis, Solar Keratosis, Skin Diseases, Precancerous Conditions, Neoplasms, SCC
- Medical subject headings
- Keratosis, Actinic, Keratosis, Skin Diseases, Precancerous Conditions, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swift SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Microwave Treatment (Swift System) | Experimental | 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. Receives: Device: Swift System |
| No Treatment | No intervention | No Treatment administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment.
Definition:
Treatment Success: complete clearance of ≥75% Actinic Keratosis lesions treated per subject, i.e., at least 75% of the AK lesions treated are fully cleared (not partially cleared).
Measured: 2 months post first treatment
Secondary outcomes (14)
Proportion of subjects with treatment success of Actinic Keratosis following Swift Microwave treatment.
Measured: 4 and 6 months post first treatment
Proportion of subjects with 100% clearance of Actinic Keratosis following Swift Microwave treatment
Measured: 2, 4 and 6 months post first treatment
Percentage of Actinic Keratosis lesions cleared across all study lesions following Swift Microwave treatment
Measured: 2, 4 and 6 months post first treatment
OCT Analysis as assessed by an AK Classification System
AK Lesions classified as Not Present, AK I (Grade I mild), AK II (Grade II, moderate) or AK III (Grade III severe)
Measured: Baseline and 2, 4 and 6 months post first treatment
Proportion of subjects with reoccurrence of any Actinic Keratosis lesions at 6 months, as classified by the blinded site investigator. The subject's AK lesion must be classified as completely resolved at 2 months to be considered a reoccurrence.
Measured: 6 months post first treatment
Level of pain during treatment using a severity scale
The subject is asked to rate the worst pain experienced during treatment as None, Mild, Moderate or Severe
Measured: Treatment 1 (Day 0), Treatment 2 (Day 28)
Level of pain after treatment using a severity scale
The subject is asked to rate the worst pain experienced during the 10 minute period after treatment is completed as None, Mild, Moderate or Severe
Measured: Treatment 1 (Day 0), Treatment 2 (Day 28)
Duration of pain after treatment using a time period scale
For subjects who experienced pain after treatment, the subject is asked to rate the duration of pain experienced during the 10 minute period after treatment using the following time period scales: a few seconds, up to 1 minute, up to 2 minutes, up to 3 minutes, Still Sore.
Measured: Treatment 1 (Day 0), Treatment 2 (Day 28)
Difference in cosmetic outcomes between treated and non-treated Actinic Keratosis as classified by the independent blinded assessors using a grading system
Photographs of each treated and non-treated AK lesion will be assessed by the independent blinded assessors for cosmetic outcome as "excellent" (slight redness or pigmentation change), "good" (moderate redness or pigmentation change), "fair" (slight-to-moderate scarring, atrophy or induration), or "poor" (extensive scarring, atrophy or induration). Each assessment compares the photos taken at the current visit against the photos taken at the previous visit. The assessments by each independent blinded assessor is recorded separately.
Measured: 2, 4 and 6 months post first treatment
Severity and occurrence of Adverse Events
Measured: Up to 12 months post first treatment
Evaluation of Patient Reported Outcome (PRO) at baseline and 6 months post first treatment using a rating scale
At Baseline, the subject will be asked to rate how their AK lesions affect their daily activities, lifestyle and mood as: none, mild, moderate and severe.
At 6-months post first treatment, the subject will be asked to rate how their daily activities, lifestyle and mood are now affected, when compared to before study treatment as: significantly better, better, unchanged, worse, significantly worse.
The results at baseline and at 6 months post first treatment will be evaluated.
Measured: Baseline and 6 months post first treatment
Evaluation of Quality of Life (QoL) questionnaires at baseline and 6 months post first treatment using the Dermatology Life Quality Index (DLQI) questionnaire
The DLQI questionnaire measures how the AK lesions have affected the subject's life over the past week. The score at baseline and at 6 months post first treatment will be evaluated.
Measured: Baseline and 6 months post first treatment
Evaluation of Cosmetic Outcome at 6 months post first treatment using a rating scale
The subject will be asked to rate the AK lesions that were treated compared to before treatment as: significantly better, better, unchanged, worse, significantly worse.
Measured: 6 months post first treatment
Long term follow-up of subjects with reoccurrence at 12 months as classified by the blinded site investigator
Measured: 12 months post first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start18 Jan 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratosis, ActinicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blackwell Device Consulting
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emblation Limited
- Responsible party
- Sponsor
- Investigators
- Professor Dirschka, Principal investigator, CentroDerm GmbH, Heinz-Fangman-Strasse 57, 42287 Wuppertal (Barmen), GermanyDr Waibel, Principal investigator, Miami Dermatology and Laser Institute, Miami, Florida, United States, 33173
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636800
- Sponsor's protocol ID
- EMBAK2
- Status last verified
- Aug 2024
- First submitted
- 14 Nov 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment for Actinic Keratosis
- ClinicalTrials.gov ID
- NCT05636800
- Acronym / sponsor ID
- EMBAK2
- Conditions
- Keratosis, Actinic
- Keywords
- Actinic Keratosis, Swift System, Microwave, Keratosis, Solar Keratosis, Skin Diseases, Precancerous Conditions, Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Blackwell Device ConsultingIndustry (pharma, biotech, devices)
- Collaborators
- Emblation Limited
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microwave Treatment (Swift System) | Experimental | Device: Swift System3-4 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. |
| No Treatment | No intervention | –No Treatment administered |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age 18-85 years inclusive (EU); 22-85 years inclusive (US).
- AK lesions for randomization in this study: Clinical diagnosis by a dermatologist of precancerous Actinic Keratosis.
- Cutaneous location.
Key exclusion criteria (18 listed)
- AK lesions at potential treatment sites on lip, nose crease, near eyes or ear.
- Confluent AK associated with field change at potential treatment sites.
- Fewer than 2 AK lesions on the left and right side of the scalp or left and right hand.
- AK lesions at potential treatment sites assessed as clinically ambiguous.
- Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable electronic devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swift SystemLocalized 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 | Device | Microwave Treatment (Swift System) |
Primary outcome
Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment.
Time frame: 2 months post first treatment
Definition: Treatment Success: complete clearance of ≥75% Actinic Keratosis lesions treated per subject, i.e., at least 75% of the AK lesions treated are fully cleared (not partially cleared).
14 secondary outcomes
Proportion of subjects with treatment success of Actinic Keratosis following Swift Microwave treatment.
Time frame: 4 and 6 months post first treatment
Proportion of subjects with 100% clearance of Actinic Keratosis following Swift Microwave treatment
Time frame: 2, 4 and 6 months post first treatment
Percentage of Actinic Keratosis lesions cleared across all study lesions following Swift Microwave treatment
Time frame: 2, 4 and 6 months post first treatment
OCT Analysis as assessed by an AK Classification System
Time frame: Baseline and 2, 4 and 6 months post first treatment
Proportion of subjects with reoccurrence of any Actinic Keratosis lesions at 6 months, as classified by the blinded site investigator. The subject's AK lesion must be classified as completely resolved at 2 months to be considered a reoccurrence.
Time frame: 6 months post first treatment
Level of pain during treatment using a severity scale
Time frame: Treatment 1 (Day 0), Treatment 2 (Day 28)
Level of pain after treatment using a severity scale
Time frame: Treatment 1 (Day 0), Treatment 2 (Day 28)
Duration of pain after treatment using a time period scale
Time frame: Treatment 1 (Day 0), Treatment 2 (Day 28)
Difference in cosmetic outcomes between treated and non-treated Actinic Keratosis as classified by the independent blinded assessors using a grading system
Time frame: 2, 4 and 6 months post first treatment
Severity and occurrence of Adverse Events
Time frame: Up to 12 months post first treatment
Evaluation of Patient Reported Outcome (PRO) at baseline and 6 months post first treatment using a rating scale
Time frame: Baseline and 6 months post first treatment
Evaluation of Quality of Life (QoL) questionnaires at baseline and 6 months post first treatment using the Dermatology Life Quality Index (DLQI) questionnaire
Time frame: Baseline and 6 months post first treatment
Evaluation of Cosmetic Outcome at 6 months post first treatment using a rating scale
Time frame: 6 months post first treatment
Long term follow-up of subjects with reoccurrence at 12 months as classified by the blinded site investigator
Time frame: 12 months post first treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swift System in people with Keratosis, Actinic, run by Blackwell Device Consulting at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment. (time frame: 2 months post first treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.