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NCT Number: NCT02670655

Efficacy of Iontophoresis-assisted AFL-PDT in Actinic Keratosis

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).

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine/prilocaine (5%) application

Drug

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

2940-nm Er:YAG AFL pretreatment

Device

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

MAL application

Drug

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.

Iontophoresis application

Device

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.

irradiation with red light-emitting diode lamp

Device

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.

Primary outcomes

  1. Differences of short-term complete response rates between three groups

    Time frame: Short-term complete response rates were evaluated at 3 months

    The lesions were classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)

  2. Differences of long-term complete response rates between three groups

    Time frame: Long-term complete response rates were evaluated at 12 months

    The lesions were classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)

  3. Differences of recurrence rates between three groups

    Time frame: Recurrence rates were evaluated at 12 months

    In addition, the recurrence rate was evaluated 12 months after treatment. For the histopathologic evaluation of treatment response, at the 12-month follow-up visit, a 3-mm punch biopsy of the treated AK lesion was performed in all cases of clinically incomplete response.

Secondary outcomes

  1. Differences of cosmetic outcomes between three groups

    Time frame: The overall cosmetic outcome was assessed 12 months after treatment

    Cosmetic outcomes were graded as excellent (slight redness or pigmentation change), good (moderate redness or pigmentation change), fair (slight-to-moderate scarring, atrophy, or induration), or poor (extensive scarring, atrophy, or induration)

Other outcomes

  1. Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between groups

    Time frame: Within 12 months after each treatment

    Adverse events reported by the patient were noted at each follow-up visit, including severity, duration and need for additional therapy. All events due to PDT were described as phototoxic reactions (i.e., erythema, post-inflammatory hyperpigmentation, oedema, itching, oozing, bleeding and so forth).

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 2, 2016
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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