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

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ClinicalTrials.gov Identifier: NCT01898936
Recruitment Status : Completed
First Posted : July 15, 2013
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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


Condition or disease Intervention/treatment
Actinic Keratosis Procedure: Pretreatment with CO2 laser before photodynamic therapy Device: Only photodynamic therapy

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Half-side Comparative Trial of Fractional Laser-assisted Daylight Photodynamic Therapy Versus Daylight Photodynamic Therapy in Organ Transplant Recipients With Multiple Actinic Keratoses of the Scalp or Forehead
Study Start Date : August 2013
Primary Completion Date : September 2016
Study Completion Date : December 2016

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Pretreatment CO2 laser

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 evaluato

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.

Sham Comparator: Only photodynamic therapy
This group will not get pretreatment with CO2 laser
Device: Only photodynamic therapy


Outcome Measures

Primary Outcome Measures :
  1. Lesion response rate defined as fraction of lesions with a complete response to treatment [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Adverse effects with emphasis on pain during illumination and following days; erythema, crusting and pustules and long-term pigmentary changes and scars. [ Time Frame: 1 week and 4 months ]

Other Outcome Measures:
  1. Graded response of all treated lesions [ Time Frame: 4 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multiple actinic keratoses (>5) in two symmetrical areas on each side of the scalp or forehead
  • OTR with stable graft function
  • More than eighteen years of age
  • Written informed consent

Exclusion Criteria:

  • Allergy to the MetvixR cream
  • Previous PDT treatment less than 6 months ago in treatment areas
  • Infiltrating tumor in treatment areas
  • Porphyria
  • Known tendency to produce hypertrophic scars and keloids
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898936


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Chair: Per Helsing, MD Oslo University Hospital
More Information

Publications:

Responsible Party: S Mohammad H Rizvi, Syed Mohammad Husain Rizvi, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01898936     History of Changes
Other Study ID Numbers: Transplant heads
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms