Actinic Keratosis Clinical Trial
Official title:
Efficacy of Iontophoresis-assisted Ablative Fractional Laser Photodynamic Therapy With Short Incubation Time for the Treatment of Actinic Keratosis: 12-month Follow-up Results of a Prospective, Randomised, Comparative Trial
Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic species across membranes and may have significant benefit for the treatment of actinic keratosis (AK) by ablative fractional laser-primed photodynamic therapy (AFL-PDT).
Photodynamic therapy (PDT) with methyl-aminolevulinate (MAL) is effective in the treatment
of actinic keratosis (AK). Many strategies have been studied to improve the production of
protoporphyrin IX (PpIX), to improve efficacy of PDT. Pre-treatment of the skin with
fractional laser resurfacing is a novel alternative technique to improve the efficacy of PDT
for AK. Our previous studies showed that ablative fractional laser-primed PDT (AFL-PDT)
offered higher efficacy than conventional MAL-PDT in the treatment of many diseases, such as
AK, actinic cheilitis, Bowen's disease and basal cell carcinoma.1-4 Iontophoresis can be
another method to improve efficacy of PDT. Iontophoresis is a transdermal drug-delivery
technique which uses a mild electric current to enhance the transport of ionic species
across membranes. Iontophoresis has been widely used to enhance drug delivery. Mizutani K et
al.5 reported 5 AK patients successfully treated with direct-current pulsed
iontophoresis-assisted 5-aminolevulinic acid (ALA)-PDT. Boddé HE et al.6 studied
iontophoretic transport of ALA quantitatively in vitro and demonstrated enhanced transport
of ALA by iontophoresis.
Until now, appropriate incubation time for AFL-PDT has not been elucidated. In our previous
study, we investigated the efficacy of AFL-PDT with a short incubation time.7 Although
AFL-PDT with a short incubation time (2 h) showed enhanced efficacy than conventional
MAL-PDT with the standard incubation time, standard AFL-PDT with 3-h incubation time showed
significantly higher efficacy than AFL-PDT with a short incubation time.
The aim of our study was to evaluate efficacy of iontophoresis in AFL-PDT for AK treatment.
Consequently, we compared efficacy, recurrence rate, cosmetic outcome and safety between
iontophoresis-assisted AFL-PDT with 2-h incubation time and conventional AFL-PDT with 2-h
and 3-h incubation times.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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