Clinical trial NCT05636800: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Keratosis, Actinic
Keywords: Actinic Keratosis
Swift System
Microwave
Keratosis
Solar Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
SCC
Lead sponsor: Blackwell Device Consulting
Sponsor class: INDUSTRY
Collaborators: name: Emblation Limited
First posted: 2022-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of subjects with treatment success of Actinic Keratosis at 2 months following Swift Microwave treatment.
timeFrame: 2 months post first treatment
Secondary outcomes:
measure: Proportion of subjects with treatment success of Actinic Keratosis following Swift Microwave treatment.
timeFrame: 4 and 6 months post first treatment
measure: Proportion of subjects with 100% clearance of Actinic Keratosis following Swift Microwave treatment
timeFrame: 2, 4 and 6 months post first treatment
measure: Percentage of Actinic Keratosis lesions cleared across all study lesions following Swift Microwave treatment
timeFrame: 2, 4 and 6 months post first treatment
measure: OCT Analysis as assessed by an AK Classification System
timeFrame: Baseline and 2, 4 and 6 months post first treatment
measure: 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.
timeFrame: 6 months post first treatment
measure: Level of pain during treatment using a severity scale
timeFrame: Treatment 1 (Day 0), Treatment 2 (Day 28)
measure: Level of pain after treatment using a severity scale
timeFrame: Treatment 1 (Day 0), Treatment 2 (Day 28)
measure: Duration of pain after treatment using a time period scale
timeFrame: Treatment 1 (Day 0), Treatment 2 (Day 28)
measure: Difference in cosmetic outcomes between treated and non-treated Actinic Keratosis as classified by the independent blinded assessors using a grading system
timeFrame: 2, 4 and 6 months post first treatment
measure: Severity and occurrence of Adverse Events
timeFrame: Up to 12 months post first treatment
measure: Evaluation of Patient Reported Outcome (PRO) at baseline and 6 months post first treatment using a rating scale
timeFrame: Baseline and 6 months post first treatment
measure: Evaluation of Quality of Life (QoL) questionnaires at baseline and 6 months post first treatment using the Dermatology Life Quality Index (DLQI) questionnaire
timeFrame: Baseline and 6 months post first treatment
measure: Evaluation of Cosmetic Outcome at 6 months post first treatment using a rating scale
timeFrame: 6 months post first treatment
measure: Long term follow-up of subjects with reoccurrence at 12 months as classified by the blinded site investigator
timeFrame: 12 months post first treatment
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Dermatology and Laser Institute
state: Florida
city: Wuppertal
country: Germany
facility: Centroderm GmbH
Study officials:
affiliation: CentroDerm GmbH, Heinz-Fangman-Strasse 57, 42287 Wuppertal (Barmen), Germany
name: Professor Dirschka
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami Dermatology and Laser Institute, Miami, Florida, United States, 33173
name: Dr Waibel
role: PRINCIPAL_INVESTIGATOR
References: