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Brief Title: Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp
Official Title: A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BF-200 ALA (Ameluz®) in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp With Photodynamic Therapy (PDT)
Study ID: NCT05060237
Brief Summary: The aim of the study is to evaluate the safety and tolerability of PDT for treatment of mild to severe actinic keratosis on the face and scalp in the expanded treatment field using 3 tubes of BF-200 ALA 10% gel (Ameluz®) in conjunction with the BF-RhodoLED® XL PDT lamp.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical Dermatology Specialists, Phoenix, Arizona, United States
Alliance Dermatology & Mohs Center, Phoenix, Arizona, United States
Dermatology Practice, Greenwood Village, Colorado, 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
Name: Todd Schlesinger, MD
Affiliation: Clinical Research Center of the Carolinas, 1364 Ashley River Road, Charleston, SC 29407, USA
Role: PRINCIPAL_INVESTIGATOR