Actinic Keratoses, Photodamaged Skin
Conditions
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.
Interventions
DEVICEPulsed-dye laser
Comparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design
DEVICEFractional CO2-laser
Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design
DRUGMetvix cream
Metvix-cream was used for photodynamic therapy in all experimental arms
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
half-side comparative randomized controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient complete (%, P) or partial clearance (%, P) | 2 year | All actinic keratoses on the particular treatment area cleared, or 75% of lesions on treatment area cleared |
| Lesion-specific clearance (%, P) | 2 year | Proportion of lesions that completely healed, partially healed or not healed in the particular treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported pain | 1 day | Maximal pain during treatment on the Numerical Rating Scale (0-10) |
Outcome results
None listed