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Microwave Treatment for Actinic Keratosis
Sponsor: Blackwell Device Consulting
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
Conditions
Interventions
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