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Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000636
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : February 24, 2012
Information provided by (Responsible Party):

Brief Summary:
The aim of this study is to determine possible molecular changes on large scale gene expression profiling after treatment with Metvix photodynamic therapy (PDT) of actinic keratoses (AK) and cancerised field in renal transplant recipients.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Procedure: Metvix PDT Phase 4

Detailed Description:

Transplant recipients have an increased propensity to develop multiple areas field of cancerisation and subsequently to develop multiple actinic keratoses, which demonstrate an increased transformation rate into invasive squamous cell carcinoma (SCC). The incidence of cutaneous premalignant epithelial lesions such as actinic keratosis (AK) is increased compared with the immunocompetent population with a mean occurrence of 38% after 5 years of immunosuppression, compared with <5% in the immunocompetent patients. Since the development of multiple AKs may portend further possibility extensive cutaneous carcinogenesis, early and aggressive treatment is essential to prevent the progression to invasive SCC.

Although they may occur as single lesion, multiple actinic keratoses (AKs) are commonly present in areas of chronic actinic damage (field of AKs or field of cancerisation). The concept of "field cancerisation" suggests that the clinically normal appearing skin around AKs provides the basis for clonal expansion of genetically altered neoplastic cells. This is called sub-clinical AK lesions.

In this study, the whole target area defined by the investigator will be treated by Metvix PDT: this means that both lesions and sub-clinical lesions will be exposed to Metvix PDT. Biopsies will be performed in both regions: lesional and peri-lesional ones. This will allow us to compare pre and post treatment molecular changes that occurred in these regions and so to evaluate if Metvix PDT acts on the sub-clinical lesions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT
Study Start Date : October 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Metvix PDT Procedure: Metvix PDT

Methyl aminolevulinate cream will be applied for 3 hours on the whole target field.

The target field will then be exposed to red light using Aktilite 128 lamp.

Primary Outcome Measures :
  1. Skin biopsies to be performed in lesional, peri-lesional skin and in healthy skin to assess gene's expression in each condition. [ Time Frame: Screening and Week 18. ]

Secondary Outcome Measures :
  1. Clinical assessment of the AKs present on the target area treated with Metvix PDT. [ Time Frame: Screening, baseline, Week 12, Week 18, Month 9 and Month15. ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Renal transplant with an history of immunosuppression from 5 to 15 years,
  • Presenting at least 4 discrete AK lesions, mild or moderate, either on the face, the scalp, forearms or the chest.

Exclusion Criteria:

  • At risk in terms of precautions, warnings, and contra-indication referred in the package insert of Metvix®,
  • AK lesions clinically atypical or suspicious for malignancy on the target field,
  • Any of the following topical treatments within the specified washout period at Screening:

    • 5-FU, Imiquimod, Diclofenac sodium: 3 months,
    • Cryotherapy: 3 months,
    • PDT: 3 months,
    • Other less common AK treatments: 3 months.
  • Systemic retinoids within the last month prior to Screening visit.

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 identifier (NCT number): NCT01000636

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United Kingdom
Department of Dermatology of Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
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Principal Investigator: John T. Lear, MB,Ch.B,M.D Manchester Royal Infirmary
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Responsible Party: Galderma Identifier: NCT01000636    
Other Study ID Numbers: RD.03.SPR.29061
Eudract # :2008-001603-30
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012
Keywords provided by Galderma:
Renal transplant patients
Actinic Keratoses
Metvix PDT
Field cancerisation
Gene expression
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents