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Microwave Treatment for Actinic Keratosis

NCT05636800 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-06

No results posted yet for this study

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

Interventions

DEVICE

Swift System

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

Sponsors & Collaborators

  • Emblation Limited

    collaborator INDUSTRY

  • Blackwell Device Consulting

    lead INDUSTRY

Principal Investigators

  • Professor Dirschka · CentroDerm GmbH, Heinz-Fangman-Strasse 57, 42287 Wuppertal (Barmen), Germany

  • Dr Waibel · Miami Dermatology and Laser Institute, Miami, Florida, United States, 33173

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2024-11-01
Completion
2024-11-01
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636800 on ClinicalTrials.gov