New Treatments for Actinic Keratoses of the Scalp

Actinic Keratoses Clinical Trial

Official title:

New Treatments for Actinic Keratoses of the Scalp

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05456334
• Other study ID #: 2016-001268-12
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 24, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 therapy.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic
• Photodamaged Skin

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Lesion-specific clearance (%, P)	Proportion of lesions that completely healed, partially healed or not healed in the particular treatment	2 year
Secondary	Patient reported pain	Maximal pain during treatment on the Numerical Rating Scale (0-10)	1 day