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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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
Miami Dermatology and Laser Institute
Miami, Florida, United States
Centroderm GmbH
Wuppertal, Germany
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).
Time frame: 2 months post first treatment
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
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
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
The subject is asked to rate the worst pain experienced during treatment as None, Mild, Moderate or Severe
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Time frame: 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
Time frame: 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.
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
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
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
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
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.
Time frame: 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.
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