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This blinded controlled 2-year study on 120 patients with 2 or more actinic keratoses, compare the efficacy and tolerability of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy compared to daylight photodynamic therapy.
Actinic keratoses are premalign skin lesions with increasing prevalence, causing a rising burden on the health care system. In this blinded controlled study we assess the efficacy of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy to daylight photodynamic therapy. It is a prospective, randomized and blinded split-head comparative study during the years 2016- 2024. 120 patients are recruited based on referral or from patients attending the clinic, with 2 or more actinic keratoses on the head, 60 to the pulsed dye-laser study and 60 to the fractional laser study. Follow-up appointments are 6 months, 1 year and 2 years post treatment. Patient reported maximal pain during treatment is documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed dye laser-mediated photodynamic therapy | Experimental | After curretage light-sensitizer (methyl aminolaevulinate cream) was applied on the lesions and covered with an occlusive plastic foil for 2-3-h incubation. Then a local lidocaine anaesthetic spray was applied. The lesions were illuminated with 30% overlapping pulsed laser double-stacked pulses (, energy 7 J/cm2, spot size 7 mm, pulse duration 10 ms, wavelength 595 nm and dynamic cooling 2/3). |
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| Conventional photodynamic therapy | Active Comparator | After curretage a light-sensitizer (methyl aminolaevulinate cream) was applied on the lesions and covered with an occlusive plastic foil for 2-3-h incubation. Then a local lidocaine anaesthetic spray was applied. The lesions were illuminated with a red LED light for 7-8 min (exposure 75 J/cm2, wavelength 630 nm). |
|
| Ablative fractional laser- mediated daylight photodynamic therapy | Experimental | After curretage lidocaine anaesthetic spray was applied on the whole treatment area. Lesions were treated with an ablative fractional CO2-laser (19 W, Dot mode, spacing 1000 µm, stack 3, scanning dwell time 1800 µs, repeat 0.5 s). A thin layer of light sensitizer (methyl aminolaevulinate cream) was applied on the treatment area. The patients were asked to move outdoors (temperature >10C, no rain, June-August) or to our adPDT-room (IndoorLux®, wavelength 350-750 nm, 15-25 000 lux) within 30 minutes, for the 2h-illumination. |
|
| Daylight photodynamic therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed-dye laser | Device | Comparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient complete (%, P) or partial clearance (%, P) | All actinic keratoses on the particular treatment area cleared, or 75% of lesions on treatment area cleared | 2 year |
| Lesion-specific clearance (%, P) | Proportion of lesions that completely healed, partially healed or not healed in the particular treatment | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported pain | Maximal pain during treatment on the Numerical Rating Scale (0-10) | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D054025 | Lasers, Dye |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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half-side comparative randomized controlled study
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After curretage lidocaine anaesthetic spray was applied on the whole treatment area. A thin layer of light sensitizer (methyl aminolaevulinate cream) was applied on the treatment area. The patients were asked to move outdoors (temperature >10C, no rain, June-August) or to our adPDT-room (IndoorLux®, wavelength 350-750 nm, 15-25 000 lux) within 30 minutes, for the 2h-illumination. |
|
| Fractional CO2-laser | Device | Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design |
|
| Metvix cream | Drug | Metvix-cream was used for photodynamic therapy in all experimental arms |
|
| D017437 |
| Skin and Connective Tissue Diseases |