Efficacy of Iontophoresis-assisted AFL-PDT in Actinic Keratosis

Dong-A University

Status and phase: Completed; Phase 1

Conditions: Actinic Keratosis

Treatments: Drug: MAL application; Device: Iontophoresis application; Drug: lidocaine/prilocaine (5%) application; Device: irradiation with red light-emitting diode lamp; Device: 2940-nm Er:YAG AFL pretreatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02670655

DAUderma-06

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 65 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Korean patients aged ≥ 18 years who had biopsy-confirmed AK lesions

Exclusion criteria

• lactating or pregnant women
• patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine
• patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment
• metal-containing device (cardiac pacemaker, orthopaedic implants, gynaecological devices)
• cardiac arrhythmia
• large skin erosion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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45 participants in 3 patient groups

Group A (short-time iontophoresis group)

Experimental group

Description:

Group A was treated with iontophoresis-assisted AFL-PDT with a short incubation time (2 h)

Treatment:

Drug: lidocaine/prilocaine (5%) application

Device: irradiation with red light-emitting diode lamp

Device: 2940-nm Er:YAG AFL pretreatment

Drug: MAL application

Device: Iontophoresis application

Group B (short-time conventional group)

Active Comparator group

Description:

Group B was treated with conventional AFL-PDT with a short incubation time (2 h)

Treatment:

Drug: lidocaine/prilocaine (5%) application

Device: irradiation with red light-emitting diode lamp

Device: 2940-nm Er:YAG AFL pretreatment

Drug: MAL application

Group C (long-time conventional group)

Active Comparator group

Description:

Group C was treated with conventional AFL-PDT with a standard incubation time (3 h)

Treatment:

Drug: lidocaine/prilocaine (5%) application

Device: irradiation with red light-emitting diode lamp

Device: 2940-nm Er:YAG AFL pretreatment

Drug: MAL application