Spots Global Cancer Trial Database for Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp
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Trial Identification
Brief Title: Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp
Official Title: A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using the BF-RhodoLED® XL or BF-RhodoLED® Lamp
Study ID: NCT05662202
Conditions
Study Description
Brief Summary: The aim of this study is to test the safety. tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medical Dermatology Specialists, Phoenix, Arizona, United States
Alliance Dermatology & Mohs Center, Phoenix, Arizona, United States
Dermatology Practice, Greenwood Village, Colorado, United States
Dermatology Associates PA of the Palm Beaches, Delray Beach, Florida, United States
Gwinnett Clinical Research Center, Inc., Snellville, Georgia, United States
Laser and Skin Surgery Center of Indiana, Indianapolis, Indiana, United States
Skin Search of Rochester, Inc., Rochester, New York, United States
Rochester Dermatologic Surgery, Victor, New York, United States
Clinical Research Center of the Carolinas, Charleston, South Carolina, United States
Austin Institute for Clinical Research, Houston, Texas, United States
Austin Institute for Clinical Research Inc., Pflugerville, Texas, United States
Contact Details
Name: Nathalie Zeitouni, MD
Affiliation: Medical Dermatology Specialists; Phoenix, Arizona, United States
Role: PRINCIPAL_INVESTIGATOR
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