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New Treatments for Actinic Keratoses of the Scalp

Primary Purpose

Photodamaged Skin, Actinic Keratoses

Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulsed-dye laser
Fractional CO2-laser
Metvix cream
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Photodamaged Skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Pulsed dye laser-mediated photodynamic therapy

    Conventional photodynamic therapy

    Ablative fractional laser- mediated daylight photodynamic therapy

    Daylight photodynamic therapy

    Arm 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).

    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).

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Patient complete (%, P) or partial clearance (%, P)
    All actinic keratoses on the particular treatment area cleared, or 75% of lesions on treatment area cleared
    Lesion-specific clearance (%, P)
    Proportion of lesions that completely healed, partially healed or not healed in the particular treatment

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 4, 2022
    Last Updated
    August 10, 2022
    Sponsor
    Helsinki University Central Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05456334
    Brief Title
    New Treatments for Actinic Keratoses of the Scalp
    Official Title
    New Treatments for Actinic Keratoses of the Scalp
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    March 24, 2016 (Actual)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Helsinki University Central Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Photodamaged Skin, Actinic Keratoses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    half-side comparative randomized controlled study
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulsed dye laser-mediated photodynamic therapy
    Arm Type
    Experimental
    Arm 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).
    Arm Title
    Conventional photodynamic therapy
    Arm Type
    Active Comparator
    Arm 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).
    Arm Title
    Ablative fractional laser- mediated daylight photodynamic therapy
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Daylight photodynamic therapy
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    Pulsed-dye laser
    Intervention Description
    Comparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design
    Intervention Type
    Device
    Intervention Name(s)
    Fractional CO2-laser
    Intervention Description
    Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design
    Intervention Type
    Drug
    Intervention Name(s)
    Metvix cream
    Intervention Description
    Metvix-cream was used for photodynamic therapy in all experimental arms
    Primary Outcome Measure Information:
    Title
    Patient complete (%, P) or partial clearance (%, P)
    Description
    All actinic keratoses on the particular treatment area cleared, or 75% of lesions on treatment area cleared
    Time Frame
    2 year
    Title
    Lesion-specific clearance (%, P)
    Description
    Proportion of lesions that completely healed, partially healed or not healed in the particular treatment
    Time Frame
    2 year
    Secondary Outcome Measure Information:
    Title
    Patient reported pain
    Description
    Maximal pain during treatment on the Numerical Rating Scale (0-10)
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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