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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
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.
Shanghai Dermatology Hospital
Shanghai, Jingan, China
RECRUITINGXiuli Wang
Shanghai, Shanghai Municipality, China
RECRUITINGThe clearance rate of Actinic Keratoses
The change rate in lesion clearance of Actinic Keratoses at two weeks after the first session will be measured as the primary outcome
Time frame: two weeks after first session
Treatment sessions
Number of treatment sessions required for clinical cure
Time frame: two weeks after the last session
Number of new Actinic Keratoses
The change in number of actinic keratoses at each follow-up will be measured as the second outcome
Time frame: 1, 3, 12 months after last session
Adverse events
Measurement of crusting, erythema, edema, pain and et al.
Time frame: 1, 3, 12 months after last session
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