New Treatments for Actinic Keratoses of the Scalp
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pulsed dye laser-mediated photodynamic therapy 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). |
Device: Pulsed-dye laser
Comparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design
Drug: Metvix cream
Metvix-cream was used for photodynamic therapy in all experimental arms
|
| Active Comparator: Conventional photodynamic therapy 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). |
Drug: Metvix cream
Metvix-cream was used for photodynamic therapy in all experimental arms
|
| Experimental: Ablative fractional laser- mediated daylight photodynamic therapy 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. |
Device: Fractional CO2-laser
Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design
Drug: Metvix cream
Metvix-cream was used for photodynamic therapy in all experimental arms
|
| Active Comparator: Daylight photodynamic therapy 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. |
Drug: Metvix cream
Metvix-cream was used for photodynamic therapy in all experimental arms
|
Outcome Measures
Primary Outcome Measures
- Patient complete (%, P) or partial clearance (%, P) [2 year]
All actinic keratoses on the particular treatment area cleared, or 75% of lesions on treatment area cleared
- Lesion-specific clearance (%, P) [2 year]
Proportion of lesions that completely healed, partially healed or not healed in the particular treatment
Secondary Outcome Measures
- Patient reported pain [1 day]
Maximal pain during treatment on the Numerical Rating Scale (0-10)
Eligibility Criteria
Criteria
Inclusion Criteria:
- at least 2 AKs located on both sides of the head (either the scalp, forehead, temples, or cheeks)
Exclusion Criteria:
- pigmented AKs, in situ-carcinomas, skin cancers, psoriasis or eczema on the treatment area
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Helsinki University Central Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016-001268-12