New Treatments for Actinic Keratoses of the Scalp

Helsinki University Central Hospital (HUCH)

Status: Active, not recruiting

Conditions: Actinic Keratoses; Photodamaged Skin

Treatments: Drug: Metvix cream; Device: Fractional CO2-laser; Device: Pulsed-dye laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05456334

2016-001268-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Pulsed dye laser-mediated photodynamic therapy

Experimental group

Description:

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).

Treatment:

Device: Pulsed-dye laser

Drug: Metvix cream

Conventional photodynamic therapy

Active Comparator group

Description:

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).

Treatment:

Drug: Metvix cream

Ablative fractional laser- mediated daylight photodynamic therapy

Experimental group

Description:

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.

Treatment:

Device: Fractional CO2-laser

Drug: Metvix cream

Daylight photodynamic therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Metvix cream