Actinic Keratoses Clinical Trial
Official title:
The Study of Plum-blossom Needling Enhancing Efficacy of Aminolevulinic Acid-photodynamic Therapy for Actinic Keratosis: a Randomized and Multi-center Clinical Trial
Background Limited in the depth of absorption and penetration of photosensitizers, ALA-PDT
treatment is not strong enough for thickening significantly AK lesions. Pre-study has proved
that plum-blossom needling facilitates delivery of topical ALA into the dermis. It could help
ALA to diffuse a little more broadly in superficial dermis and obtain similar clinical effect
with a much lower cost.
Objective We sought to investigate whether plum-blossom needling (PBN) would enhance the
efficacy of ALA-PDT for AKs.
Methods Two hundred and fifty patients, previously diagnosed as having AKs of the face and
scalp, were randomized distribution into two groups. The PBN-ALA-PDT group underwent vertical
skin tapping with PBN before applying 10% ALA cream and narrow-band light-emitting diode
(LED) irradiation (mean 633 nm, with a standard deviation [SD] of 10 nm; 100-200 J/cm2). The
ALA-PDT group received ALA cream and irradiation only. During the next 1 year period of
follow up, patients were clinically evaluated for new AKs.
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