New Treatments for Actinic Keratoses of the Scalp

Not Applicable

Active, not recruiting

• Conditions: Photodamaged Skin; Actinic Keratoses
• Interventions: Device: Pulsed-dye laser; Device: Fractional CO2-laser; Drug: Metvix cream

• Registration Number: NCT05456334
• Lead Sponsor: Helsinki University Central Hospital

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.

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 Timeline

• Study Start: 2016-03-24
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-21
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed dye laser-mediated photodynamic therapy	Metvix cream	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).
Conventional photodynamic therapy	Metvix cream	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	Metvix cream	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	Metvix cream	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.
Pulsed dye laser-mediated photodynamic therapy	Pulsed-dye laser	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).
Ablative fractional laser- mediated daylight photodynamic therapy	Fractional CO2-laser	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.

Primary Outcome Measures

Name	Time	Method
Lesion-specific clearance (%, P)	2 year	Proportion of lesions that completely healed, partially healed or not healed in the particular treatment
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

Secondary Outcome Measures

Name	Time	Method
Patient reported pain	1 day	Maximal pain during treatment on the Numerical Rating Scale (0-10)