New Treatments for Actinic Keratoses of the Scalp

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Actinic Keratoses; Photodamaged Skin
• Intervention / Treatment: Device: Pulsed-dye laser; Drug: Metvix cream; Device: Fractional CO2-laser

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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.	Drug: Metvix cream; Metvix-cream was used for photodynamic therapy in all experimental arms; Device: Fractional CO2-laser; Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2016
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Methyl 5-aminolevulinate
• Other Study ID Numbers: 2016-001268-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No