Back to resultsMicrowave Treatment for Actinic Keratosis
Primary Purpose
Keratosis, Actinic
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Swift System
Sponsored by
About this trial
This is an interventional treatment trial for Keratosis, Actinic focused on measuring Actinic Keratosis, Swift System, Microwave, Keratosis, Solar Keratosis, Skin Diseases, Precancerous Conditions, Neoplasms, SCC
Eligibility Criteria
Inclusion Criteria: 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). 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. Exclusion Criteria: 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. 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.
Sites / Locations
- Miami Dermatology and Laser InstituteRecruiting
- Centroderm GmbHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Microwave Treatment (Swift System)
No Treatment
Arm Description
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.
No Treatment administered
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Proportion of subjects with treatment success of Actinic Keratosis following Swift Microwave treatment.
Proportion of subjects with 100% clearance of Actinic Keratosis following Swift Microwave treatment
Percentage of Actinic Keratosis lesions cleared across all study lesions following Swift Microwave 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)
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.
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
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
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.
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.
Severity and occurrence of Adverse Events
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.
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.
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.
Long term follow-up of subjects with reoccurrence at 12 months as classified by the blinded site investigator
Full Information
NCT ID
NCT05636800
First Posted
November 14, 2022
Last Updated
May 5, 2023
Sponsor
Blackwell Device Consulting
Collaborators
Emblation Limited
1. Study Identification
Unique Protocol Identification Number
NCT05636800
Brief Title
Microwave Treatment for Actinic Keratosis
Official Title
Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment for Actinic Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
April 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blackwell Device Consulting
Collaborators
Emblation Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis, Actinic
Keywords
Actinic Keratosis, Swift System, Microwave, Keratosis, Solar Keratosis, Skin Diseases, Precancerous Conditions, Neoplasms, SCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microwave Treatment (Swift System)
Arm Type
Experimental
Arm Description
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.
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
No Treatment administered
Intervention Type
Device
Intervention Name(s)
Swift System
Intervention 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
Primary Outcome Measure Information:
Title
Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment.
Description
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).
Time Frame
2 months post first treatment
Secondary Outcome Measure Information:
Title
Proportion of subjects with treatment success of Actinic Keratosis following Swift Microwave treatment.
Time Frame
4 and 6 months post first treatment
Title
Proportion of subjects with 100% clearance of Actinic Keratosis following Swift Microwave treatment
Time Frame
2, 4 and 6 months post first treatment
Title
Percentage of Actinic Keratosis lesions cleared across all study lesions following Swift Microwave treatment
Time Frame
2, 4 and 6 months post first treatment
Title
OCT Analysis as assessed by an AK Classification System
Description
AK Lesions classified as Not Present, AK I (Grade I mild), AK II (Grade II, moderate) or AK III (Grade III severe)
Time Frame
Baseline and 2, 4 and 6 months post first treatment
Title
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
Title
Level of pain during treatment using a severity scale
Description
The subject is asked to rate the worst pain experienced during treatment as None, Mild, Moderate or Severe
Time Frame
Treatment 1 (Day 0), Treatment 2 (Day 28)
Title
Level of pain after treatment using a severity scale
Description
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
Time Frame
Treatment 1 (Day 0), Treatment 2 (Day 28)
Title
Duration of pain after treatment using a time period scale
Description
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.
Time Frame
Treatment 1 (Day 0), Treatment 2 (Day 28)
Title
Difference in cosmetic outcomes between treated and non-treated Actinic Keratosis as classified by the independent blinded assessors using a grading system
Description
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.
Time Frame
2, 4 and 6 months post first treatment
Title
Severity and occurrence of Adverse Events
Time Frame
Up to 12 months post first treatment
Title
Evaluation of Patient Reported Outcome (PRO) at baseline and 6 months post first treatment using a rating scale
Description
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.
Time Frame
Baseline and 6 months post first treatment
Title
Evaluation of Quality of Life (QoL) questionnaires at baseline and 6 months post first treatment using the Dermatology Life Quality Index (DLQI) questionnaire
Description
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.
Time Frame
Baseline and 6 months post first treatment
Title
Evaluation of Cosmetic Outcome at 6 months post first treatment using a rating scale
Description
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.
Time Frame
6 months post first treatment
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emblation
Phone
+44 (0)1786 657223
Email
clinical@emblation.com
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Dirschka
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Dirschka
Organizational Affiliation
CentroDerm GmbH, Heinz-Fangman-Strasse 57, 42287 Wuppertal (Barmen), Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Waibel
Organizational Affiliation
Miami Dermatology and Laser Institute, Miami, Florida, United States, 33173
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Dermatology and Laser Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N Reith
Phone
305-279-6060
Email
clinicaltrials@miamidermlaser.com
Facility Name
Centroderm GmbH
City
Wuppertal
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S Strack
Phone
+49 (0)202 - 629 337 -36
12. IPD Sharing Statement
Learn more about this trial
Microwave Treatment for Actinic Keratosis
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