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Fractional Laser-assisted Daylight Photodynamic Therapy Versus Daylight Photodynamic for Treatment of Actinic Keratoses

NCT01898936 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-10-09

No results posted yet for this study

Summary

Organ transplant recipients (OTR) have an increased risk of non-melanoma skin cancer, in particular squamous cell carcinoma (SCC), often developing in areas of field cancerization, areas with multiple precancerous actinic keratoses. The risk of developing SCC in OTR is 65-100-fold the normal population (Jensen 1999, Lindeløf 2000), and this cancer often runs a more aggressive course with metastasis reported to occur in 5-8% of cases (Berg 2002). The treatment options in field cancerization are limited. In Norway, the registered treatment alternatives are the topical immune response modifier imiquimod and photodynamic treatment. Neither of these treatments has shown long term beneficial effects.

In this study, we will study the effect of pre-treating the skin with ablative, fractional carbondioxide laser before photodynamic therapy in a group of OTR with multiple actinic keratoses

Conditions

  • Actinic Keratosis

Interventions

PROCEDURE

Pretreatment with CO2 laser before photodynamic therapy

The treatment will be a field treatment performed with a 30 W Lutronic carbondioxide laser; covering one of the symmetrical treatment areas allocated to fractional carbondioxide laser. The laser settings will be as follows: The fluence will initially be 10mJ/cm2 delivered with a 120 micron tip (producing 120 micron ablative columns) with 5% density. The fluence will be increased until the patient experiences pain (pain indicating penetration to dermis), and then reduced to maximum fluence without pain. Allocation to laser therapy is blinded for the future evaluator. The PDT procedure includes application of Metvix cream on the skin on both symmetrical areas with a thickness of approximately 1 mm, plastic covering for 30 minutes before entering daylight for 2 hours.

DEVICE

Only photodynamic therapy

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Per Helsing, MD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-09-30
Completion
2016-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01898936 on ClinicalTrials.gov