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Fractional laser assisted photodynamic therapy in actinic keratosis: A pilot study

Fractional laser assisted photodynamic therapy in actinic keratosis: A pilot study - Fractional laser assisted PDT in Actinic keratosis

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57215
Enrollment
10
Registered
2012-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

actinic keratosis sun damaged skin

Interventions

UltraPulse, fractional CO2, Lumenis, 10.600 nm, 10 mJ/pulse, 0.12 mm spot size, 5% ablation rate

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Caucasian patients > 30 years Fitzpatrick skin type I-III Clinically proven Actinic Keratoss on vertex and/or forehead

Exclusion criteria

Exclusion criteria: Prior treatment of AK within the past 6 months Suspicion for malignancy Known hypersensibility for ALA/MAL photosensitizers Use of Diclofenac gel, tretinoine cream, salicylic acid and/or topical corticosteroids in the past 6 months on vertex and/or forehead Psoriasis and/or eczema on vertex and/or forehead

Design outcomes

Primary

MeasureTime frame
Primaire outcome: * Effectiveness of AFR pre-treatment in PDL laser assisted PDT for AK * Reduction of incubation time topical PDT drugs (MAL/Metvix) with 50% using AFR density 50%.—

Secondary

MeasureTime frame
Secondaire outcome: * Patient satisfaction * Pain score (VAS) * Complications/adverse outcomes * Duration of treatment * Cost of treatment This has to be proved with a randomized controlled study later on.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)