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

NCT01898936 | Completed

• 1 other identifier: Transplant heads
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• Lesion response rate defined as fraction of lesions with a complete response to treatment

  4 months

Secondary Outcomes (1)

• Adverse effects with emphasis on pain during illumination and following days; erythema, crusting and pustules and long-term pigmentary changes and scars.

  1 week and 4 months

Other Outcomes (1)

• Graded response of all treated lesions

  4 months

Study Arms (2)

Pretreatment CO2 laser

EXPERIMENTAL

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

Only photodynamic therapy

SHAM COMPARATOR

This group will not get pretreatment with CO2 laser

Device: Only photodynamic therapy

Interventions

Pretreatment with CO2 laser before photodynamic therapy PROCEDURE

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.

Pretreatment CO2 laser

Only photodynamic therapy DEVICE

Only photodynamic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (10)

• Berg 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 BACKGROUND

• Christensen 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 BACKGROUND

• Dragieva 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 BACKGROUND

• Haedersdal 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 BACKGROUND

• Jensen 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 BACKGROUND

• Lindelof 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 BACKGROUND

• Morton 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.

  PMID: 11966684 BACKGROUND

• Olsen EA, Abernethy ML, Kulp-Shorten C, Callen JP, Glazer SD, Huntley A, McCray M, Monroe AB, Tschen E, Wolf JE Jr. A double-blind, vehicle-controlled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck. J Am Acad Dermatol. 1991 May;24(5 Pt 1):738-43. doi: 10.1016/0190-9622(91)70113-g.

  PMID: 1869646 BACKGROUND

• Tschen EH, Wong DS, Pariser DM, Dunlap FE, Houlihan A, Ferdon MB; Phase IV ALA-PDT Actinic Keratosis Study Group. Photodynamic therapy using aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the face and scalp: phase IV multicentre clinical trial with 12-month follow up. Br J Dermatol. 2006 Dec;155(6):1262-9. doi: 10.1111/j.1365-2133.2006.07520.x.

  PMID: 17107399 BACKGROUND

• Wiegell SR, Haedersdal M, Philipsen PA, Eriksen P, Enk CD, Wulf HC. Continuous activation of PpIX by daylight is as effective as and less painful than conventional photodynamic therapy for actinic keratoses; a randomized, controlled, single-blinded study. Br J Dermatol. 2008 Apr;158(4):740-6. doi: 10.1111/j.1365-2133.2008.08450.x. Epub 2008 Feb 19.

  PMID: 18294318 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Per Helsing, MD

  Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Syed Mohammad Husain Rizvi

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 15, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

NO (1)