Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol
NCT ID: NCT02644187
Last Updated: 2017-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2015-12-31
2017-03-31
Brief Summary
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The study design will have an open and prospective, two-armed, split-face design. Participants with AK lesions distributed symmetrically on the scalp, forehead, cheeks, torso, back, arms and/or dorsal parts of the hands are eligible for inclusion. The purpose is to investigate if a modified irradiation protocol can lower the pain while having the same effect on AK clearance rates as compared to the standard PDT irradiation protocol.
Before any study-related procedures are performed, the participants will be thoroughly informed about the study and will be given the opportunity to ask questions. The participants will thereafter sign and date the informed consent form. This constitutes as visit 0.
On visit 1, a randomization to either the standard or the modified irradiation protocol will be performed on one side of the face/body and the other irradiation protocol will then be applied on the other side of the face/body. The participants should have AKs on two comparable sites, i.e. two cheeks, arms or dorsal parts of the hands. One side will be randomized to receive PDT with BF200-ALA and irradiation with the RhodoLED® lamp and the other side will receive BF200-ALA and the Aktilite CL-128 lamp (PhotoCure ASA, Oslo, Norway), which is the traditional lamp used at our department as mentioned above.
The treatment will be given at visit 1. During the treatment, the participants will be asked continuously, every third minute, to estimate the pain on each treatment side using the visual analogue scale, VAS, (where 0 is no pain and 10 is the worst pain imaginable). At the end of the treatment, the participants will also be asked to summarize the treatment as a whole on the VAS-scale. After visit 1, the participants will fill in a follow-up diary form with questions regarding adverse effects (AEs) during the hours and days after the treatment. The efficacy of the treatment will also be assessed at a follow-up (FU) visit, visit 2. The investigators are aiming for a non-inferior analysis, i.e. the new modified irradiation protocol should be at least as good as the standard irradiation protocol. The randomization is blinded for the investigator at the FU visit to minimize the possibility of favoring one irradiation protocol.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Left side first -Aktilite CL128
Randomized left side first with application of 5-aminolevulinic acid under occlusion during 3h. After that Aktilite CL128.
Aktilite CL128
Infrared light, with total dose of 37J/cm2.
BF200-ALA/5-aminolevulinic acid
Prodrug applied to whole treatment area previous to illumination with either light source.
Right side first -Aktilite CL128
Randomized right side first with application of 5-aminolevulinic acid under occlusion during 3h. After that Aktilite CL128.
Aktilite CL128
Infrared light, with total dose of 37J/cm2.
BF200-ALA/5-aminolevulinic acid
Prodrug applied to whole treatment area previous to illumination with either light source.
Left side first -BF-RhodoLED
Randomized left side first with application of 5-aminolevulinic acid under occlusion during 3h. After that BF-RhodoLED.
BF-RhodoLED
Infrared light, with total dose of 37J/cm2.
BF200-ALA/5-aminolevulinic acid
Prodrug applied to whole treatment area previous to illumination with either light source.
Right side first -BF-RhodoLED
Randomized right side first with application of 5-aminolevulinic acid under occlusion during 3h. After that BF-RhodoLED.
BF-RhodoLED
Infrared light, with total dose of 37J/cm2.
BF200-ALA/5-aminolevulinic acid
Prodrug applied to whole treatment area previous to illumination with either light source.
Interventions
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BF-RhodoLED
Infrared light, with total dose of 37J/cm2.
Aktilite CL128
Infrared light, with total dose of 37J/cm2.
BF200-ALA/5-aminolevulinic acid
Prodrug applied to whole treatment area previous to illumination with either light source.
Eligibility Criteria
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Inclusion Criteria
* Patients \>18 years of age who have signed a written informed consent.
Exclusion Criteria
* Participating in other clinical study at the same time or within 30 days.
* Conditions associated with poor protocol compliance, e.g. excessive use of alcohol or drug abuse.
18 Years
ALL
No
Sponsors
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Vastra Gotaland Region
OTHER_GOV
Responsible Party
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John Paoli
MD, Assoc. Prof.
Principal Investigators
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John Paoli, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Dep. of Dermatology, Sahlgrenska University Hospital
Locations
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Dep. of Dermatology, Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Other Identifiers
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VastraGotaland
Identifier Type: -
Identifier Source: org_study_id
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