Photodamaged SkinNCT05456334
New Treatments for Actinic Keratoses of the Scalp
A study testing Pulsed-dye laser, Fractional CO2-laser and Metvix cream in people with Photodamaged Skin and Actinic Keratoses, run by Helsinki University Central Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Photodamaged Skin, Actinic Keratoses
- What is being tested?
- Pulsed-dye laser, Fractional CO2-laser and Metvix cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 24 Mar 2016to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 2 AKs located on both sides of the head (either the scalp, forehead, temples, or cheeks)
Who cannot join
- pigmented AKs, in situ-carcinomas, skin cancers, psoriasis or eczema on the treatment area
About this study
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.
Read the 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.
- Conditions
- Photodamaged Skin, Actinic Keratoses
- Being tested
- Pulsed-dye laser, Fractional CO2-laser, Metvix cream
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: 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. Receives: Drug: Metvix cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient complete (%, P) or partial clearance (%, P)
All actinic keratoses on the particular treatment area cleared, or 75% of lesions on treatment area cleared
Measured: 2 year
Lesion-specific clearance (%, P)
Proportion of lesions that completely healed, partially healed or not healed in the particular treatment
Measured: 2 year
Secondary outcomes (1)
Patient reported pain
Maximal pain during treatment on the Numerical Rating Scale (0-10)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start24 Mar 2016
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- half-side comparative randomized controlled study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsi Isoherranen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456334
- Sponsor's protocol ID
- 2016-001268-12
- Other IDs
- 2016
- Status last verified
- Nov 2023
- First submitted
- 4 Jul 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Treatments for Actinic Keratoses of the Scalp
- ClinicalTrials.gov ID
- NCT05456334
- Acronym / sponsor ID
- 2016-001268-12
- Conditions
- Photodamaged Skin, Actinic Keratoses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 24 Mar 2016 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- half-side comparative randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Pulsed dye laser-mediated photodynamic therapy | Experimental | Device: Pulsed-dye laser, Drug: Metvix creamAfter 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). |
| Conventional photodynamic therapy | Active comparator | Drug: Metvix creamAfter 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). |
| Ablative fractional laser- mediated daylight photodynamic therapy | Experimental | Device: Fractional CO2-laser, Drug: Metvix creamAfter 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. |
| Daylight photodynamic therapy | Active comparator | Drug: Metvix creamAfter 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- at least 2 AKs located on both sides of the head (either the scalp, forehead, temples, or cheeks)
Key exclusion criteria (1 listed)
- pigmented AKs, in situ-carcinomas, skin cancers, psoriasis or eczema on the treatment area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed-dye laserComparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design | Device | Pulsed dye laser-mediated photodynamic therapy |
| Fractional CO2-laserComparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design | Device | Ablative fractional laser- mediated daylight photodynamic therapy |
| Metvix creamMetvix-cream was used for photodynamic therapy in all experimental arms | Drug | Ablative fractional laser- mediated daylight photodynamic therapy, Conventional photodynamic therapy, Daylight photodynamic therapy, Pulsed dye laser-mediated photodynamic therapy |
Primary outcome
Patient complete (%, P) or partial clearance (%, P)
Time frame: 2 year
All actinic keratoses on the particular treatment area cleared, or 75% of lesions on treatment area cleared
Lesion-specific clearance (%, P)
Time frame: 2 year
Proportion of lesions that completely healed, partially healed or not healed in the particular treatment
1 secondary outcome
Patient reported pain
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed-dye laser, Fractional CO2-laser and Metvix cream in people with Photodamaged Skin and Actinic Keratoses, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient complete (%, P) or partial clearance (%, P) (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.