New Treatments for Actinic Keratoses of the Scalp

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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New Treatments for Actinic Keratoses of the Scalp

Conditions
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Photodamaged Skin, Actinic Keratoses

Intervention / Treatment
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* Device: Pulsed-dye laser
* Device: Fractional CO2-laser
* Drug: Metvix cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: half-side comparative randomized controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed dye laser-mediated photodynamic therapy<br>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<br>* Comparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design<br>Drug: Metvix cream<br>* Metvix-cream was used for photodynamic therapy in all experimental arms<br>|
| Active Comparator: Conventional photodynamic therapy<br>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<br>* Metvix-cream was used for photodynamic therapy in all experimental arms<br>|
| Experimental: Ablative fractional laser- mediated daylight photodynamic therapy<br>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<br>* Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design<br>Drug: Metvix cream<br>* Metvix-cream was used for photodynamic therapy in all experimental arms<br>|
| Active Comparator: Daylight photodynamic therapy<br>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<br>* Metvix-cream was used for photodynamic therapy in all experimental arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported pain | Maximal pain during treatment on the Numerical Rating Scale (0-10) | 1 day |