Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01000636
First received: October 22, 2009
Last updated: February 23, 2012
Last verified: February 2012

October 22, 2009
February 23, 2012
October 2009
October 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01000636 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Actinic Keratosis
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.

Other Name: Metvix PDT
Experimental: Metvix PDT
Intervention: Procedure: Metvix PDT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01000636
RD.03.SPR.29061, Eudract # :2008-001603-30
No
Galderma
Galderma
Not Provided
Principal Investigator: John T. Lear, MB,Ch.B,M.D Manchester Royal Infirmary
Galderma
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP