Efficacy of Iontophoresis-assisted AFL-PDT in Actinic Keratosis
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedFebruary 2, 2016
January 1, 2016
1.5 years
January 28, 2016
January 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Differences of short-term complete response rates between three groups
The lesions were classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Short-term complete response rates were evaluated at 3 months
Differences of long-term complete response rates between three groups
The lesions were classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
Long-term complete response rates were evaluated at 12 months
Differences of recurrence rates between three groups
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.
Recurrence rates were evaluated at 12 months
Secondary Outcomes (1)
Differences of cosmetic outcomes between three groups
The overall cosmetic outcome was assessed 12 months after treatment
Other Outcomes (1)
Difference of adverse events (erythema, post-inflammatory hyperpigmentation, edema, itching, oozing, bleeding) rates between groups
Within 12 months after each treatment
Study Arms (3)
Group A (short-time iontophoresis group)
EXPERIMENTALGroup A was treated with iontophoresis-assisted AFL-PDT with a short incubation time (2 h)
Group B (short-time conventional group)
ACTIVE COMPARATORGroup B was treated with conventional AFL-PDT with a short incubation time (2 h)
Group C (long-time conventional group)
ACTIVE COMPARATORGroup C was treated with conventional AFL-PDT with a standard incubation time (3 h)
Interventions
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
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
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Korean patients aged ≥ 18 years who had biopsy-confirmed AK lesions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
January 28, 2016
First Posted
February 2, 2016
Study Start
June 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 2, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share