NCT05456334

New Treatments for Actinic Keratoses of the Scalp

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Photodamaged Skin
• Actinic Keratoses

Interventions

Type	Name	Description
DEVICE	Pulsed-dye laser	Comparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design
DEVICE	Fractional CO2-laser	Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design
DRUG	Metvix cream	Metvix-cream was used for photodynamic therapy in all experimental arms

Timeline

• Start date: 2016-03-24
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2022-07-13
• Last updated: 2023-11-21