Clinical trial · Interventional
Fractional Laser-assisted Daylight Photodynamic Therapy Versus Daylight Photodynamic for Treatment of Actinic Keratoses
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Only photodynamic therapy | Device | — | UNRESOLVED |
| Pretreatment with CO2 laser before photodynamic therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pretreatment CO2 laser
- description
- 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
- interventionNames
- Procedure: Pretreatment with CO2 laser before photodynamic therapy
- type
- SHAM_COMPARATOR
- label
- Only photodynamic therapy
- description
- This group will not get pretreatment with CO2 laser
- interventionNames
- Device: Only photodynamic therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDBerg D, Otley CC. Skin cancer in organ transplant recipients: Epidemiology, pathogenesis, and management. J Am Acad Dermatol. 2002 Jul;47(1):1-17; quiz 18-20. doi: 10.1067/mjd.2002.125579. PMID 12077575
- BACKGROUNDChristensen E, Warloe T, Kroon S, Funk J, Helsing P, Soler AM, Stang HJ, Vatne O, Mork C; Norwegian Photodynamic Therapy (PDT) Group. Guidelines for practical use of MAL-PDT in non-melanoma skin cancer. J Eur Acad Dermatol Venereol. 2010 May;24(5):505-12. doi: 10.1111/j.1468-3083.2009.03430.x. Epub 2009 Oct 6. PMID 19807828
- BACKGROUNDDragieva G, Prinz BM, Hafner J, Dummer R, Burg G, Binswanger U, Kempf W. A randomized controlled clinical trial of topical photodynamic therapy with methyl aminolaevulinate in the treatment of actinic keratoses in transplant recipients. Br J Dermatol. 2004 Jul;151(1):196-200. doi: 10.1111/j.1365-2133.2004.06054.x. PMID 15270891
- BACKGROUNDHaedersdal M, Sakamoto FH, Farinelli WA, Doukas AG, Tam J, Anderson RR. Fractional CO(2) laser-assisted drug delivery. Lasers Surg Med. 2010 Feb;42(2):113-22. doi: 10.1002/lsm.20860. PMID 20166154
- BACKGROUNDJensen P, Hansen S, Moller B, Leivestad T, Pfeffer P, Geiran O, Fauchald P, Simonsen S. Skin cancer in kidney and heart transplant recipients and different long-term immunosuppressive therapy regimens. J Am Acad Dermatol. 1999 Feb;40(2 Pt 1):177-86. doi: 10.1016/s0190-9622(99)70185-4. PMID 10025742
- BACKGROUNDLindelof B, Sigurgeirsson B, Gabel H, Stern RS. Incidence of skin cancer in 5356 patients following organ transplantation. Br J Dermatol. 2000 Sep;143(3):513-9. PMID 10971322
- BACKGROUNDMorton CA, Brown SB, Collins S, Ibbotson S, Jenkinson H, Kurwa H, Langmack K, McKenna K, Moseley H, Pearse AD, Stringer M, Taylor DK, Wong G, Rhodes LE. Guidelines for topical photodynamic therapy: report of a workshop of the British Photodermatology Group. Br J Dermatol. 2002 Apr;146(4):552-67. doi: 10.1046/j.1365-2133.2002.04719.x.