New Treatments for Actinic Keratoses of the Scalp

Helsinki University Central Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Photodamaged Skin Actinic Keratoses

Interventions

Pulsed-dye laserDEVICE

Comparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design

Fractional CO2-laserDEVICE

Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design

Metvix creamDRUG

Metvix-cream was used for photodynamic therapy in all experimental arms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient complete (%, P) or partial clearance (%, P)

All actinic keratoses on the particular treatment area cleared, or 75% of lesions on treatment area cleared

Time frame: 2 year

Lesion-specific clearance (%, P)

Proportion of lesions that completely healed, partially healed or not healed in the particular treatment

Time frame: 2 year

Secondary Outcomes

Patient reported pain

Maximal pain during treatment on the Numerical Rating Scale (0-10)

Time frame: 1 day

Data from ClinicalTrials.gov

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