Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
Background Actinic keratoses (AKs) are often treated separately, lesion by lesion. However,
in the past years, AKs have been described as a field disease and not limited to single
clinically apparent lesions. Treatment should therefore target an area of field change which
may treat the subclinical AKs and reduce the risk of development of further AKs, second
tumours, and local recurrence.
Objectives The investigators sought to investigate whether field ALA-PDT of facial actinic
keratosis would prevent new AKs, in comparison with a lesion area receiving the same ALA-PDT,
in patients with clinical signs of field cancerization.
Methods Eighty patients, previously diagnosed as having AKs of the face, were randomized
distribution into two groups. 10% aminolaevulinic acid (ALA)-PDT for field treatment was on
one group and for a lesion area (Vehicle control cream was applied to the non-lesion area)
was on the other group. During the next 5-year period of follow up, patients were clinically
evaluated for new AKs.
Phase:
Phase 4
Details
Lead Sponsor:
Shanghai Dermatology Hospital
Collaborators:
Chinese Academy of Medical Sciences General Hospital of Ningxia Medical University Huadong Hospital Peking University First Hospital The First Affiliated Hospital of Kunming Medical College