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Trial record 19 of 38 for:    Open Studies | "Keratosis, Actinic"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
S Mohammad H Rizvi, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01898936
First received: July 1, 2013
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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 Intervention
Actinic Keratosis
Procedure: Pretreatment with CO2 laser before photodynamic therapy
Device: Only photodynamic therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Lesion response rate defined as fraction of lesions with a complete response to treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Graded response of all treated lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
After curettage/debulking, the BCC is incubated with MAL cream (Metvix® cream, Galderma, France), occluded for three hours under a plastic film and illuminated with red light-emitting diode light (LED) at 632 nm at a dosage of 37 J/cm2 (Aktilite®, Galderma, Oslo, Norway).

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898936

Contacts
Contact: Mohammad Rizvi, MD 0047 23070000
Contact: Per Helsing, MD 0047 23070000

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Mohammad Rizvi, MD    0047 23070000    mohammad.rizvi@ous-hf.no   
Principal Investigator: Mohammad Rizvi, MD         
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
Study First Received: July 1, 2013
Last Updated: October 17, 2014
Health Authority: Norway: Norwegian health department

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

ClinicalTrials.gov processed this record on November 27, 2014