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ACTIVE NOT RECRUITING
NCT05636800
NA

Microwave Treatment for Actinic Keratosis

Sponsor: Blackwell Device Consulting

View on ClinicalTrials.gov

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.

Official title: Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment for Actinic Keratosis

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-01-18

Completion Date

2024-11-01

Last Updated

2024-08-06

Healthy Volunteers

No

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

Locations (2)

Miami Dermatology and Laser Institute

Miami, Florida, United States

Centroderm GmbH

Wuppertal, Germany