Microwave Treatment for Actinic Keratosis

NCT05636800 | Active Not Recruiting FDA Device

• 1 other identifier: EMBAK2
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Keratosis, Actinic

Keywords

Actinic Keratosis; Swift System; Microwave; Keratosis; Solar Keratosis; Skin Diseases; Precancerous Conditions; Neoplasms; SCC

Outcome Measures

Primary Outcomes (1)

• 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).

  2 months post first treatment

Secondary Outcomes (14)

• Proportion of subjects with treatment success of Actinic Keratosis following Swift Microwave treatment.

  4 and 6 months post first treatment

• Proportion of subjects with 100% clearance of Actinic Keratosis following Swift Microwave treatment

  2, 4 and 6 months post first treatment

• Percentage of Actinic Keratosis lesions cleared across all study lesions following Swift Microwave treatment

  2, 4 and 6 months post first treatment

• OCT Analysis as assessed by an AK Classification System

  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.

  6 months post first treatment

Study Arms (2)

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.

Device: Swift System

No Treatment

NO INTERVENTION

No Treatment administered

Interventions

Swift System 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

Microwave Treatment (Swift System)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• , 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blackwell Device Consulting: lead
• Emblation Limited: collaborator

Study Sites (2)

Miami Dermatology and Laser Institute

Miami, Florida, 33173, United States

Location

Centroderm GmbH

Wuppertal, Germany

Location

MeSH Terms

Conditions

Keratosis, Actinic; Keratosis; Skin Diseases; Precancerous Conditions; Neoplasms

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Professor Dirschka

  CentroDerm GmbH, Heinz-Fangman-Strasse 57, 42287 Wuppertal (Barmen), Germany

  PRINCIPAL INVESTIGATOR

• Dr Waibel

  Miami Dermatology and Laser Institute, Miami, Florida, United States, 33173

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: December 5, 2022
• Study Start: January 18, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

US (1); DE (1)