New Treatments for Actinic Keratoses of the Scalp

NCT05456334 | Unknown

• 1 other identifier: 2016-001268-12
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Photodamaged Skin; Actinic Keratoses

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Patient reported pain

  1 day

Study Arms (4)

Pulsed dye laser-mediated photodynamic therapy

EXPERIMENTAL

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; Drug: Metvix cream

Conventional photodynamic therapy

ACTIVE COMPARATOR

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

Ablative fractional laser- mediated daylight photodynamic therapy

EXPERIMENTAL

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; Drug: Metvix cream

Daylight photodynamic therapy

ACTIVE COMPARATOR

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

Interventions

Pulsed-dye laser DEVICE

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

Pulsed dye laser-mediated photodynamic therapy

Fractional CO2-laser DEVICE

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

Ablative fractional laser- mediated daylight photodynamic therapy

Metvix cream DRUG

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

Ablative fractional laser- mediated daylight photodynamic therapy; Conventional photodynamic therapy; Daylight photodynamic therapy; Pulsed dye laser-mediated photodynamic therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 2 AKs located on both sides of the head (either the scalp, forehead, temples, or cheeks)

You may not qualify if:

• pigmented AKs, in situ-carcinomas, skin cancers, psoriasis or eczema on the treatment area

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: half-side comparative randomized controlled study

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 13, 2022
• Study Start: March 24, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share