Efficacy of Iontophoresis-assisted AFL-PDT in Actinic Keratosis

PHASE1CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Actinic Keratosis
Interventions
DRUG

lidocaine/prilocaine (5%) application

For AFL pre-treatment, lidocaine/prilocaine (5%) cream (EMLA; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area under occlusion for 30 min

DEVICE

2940-nm Er:YAG AFL pretreatment

After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550 µm ablation depth, level 1 coagulation, 22% treatment density and a single pulse

DRUG

MAL application

Immediately after AFL treatment, an approximately 1-mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue.

DEVICE

Iontophoresis application

In Group A, ionotophoresis was performed on MAL-applied sites. We used iontophoresis (vitaliont II®, ITC Inc, Korea) with a patch. The active electrode was the anode, and 0.50-mA/cm2 current was applied to each AK lesion for 10 min.

DEVICE

irradiation with red light-emitting diode lamp

After incubation for 2 (Group A and B) or 3 hours (Group C), the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface, and a total light dose of 37 J/cm-2. All patients wore protective goggles during illumination.

All Listed Sponsors
lead

Dong-A University

OTHER

NCT02670655 - Efficacy of Iontophoresis-assisted AFL-PDT in Actinic Keratosis | Biotech Hunter | Biotech Hunter