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Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT

Phase 4
18 Years
Not Enrolling
Actinic Keratosis

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Trial Information

Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Skin biopsies to be performed in lesional, peri-lesional skin and in healthy skin to assess gene's expression in each condition.

Outcome Time Frame:

Screening and Week 18.

Safety Issue:


Principal Investigator

John T. Lear, MB,Ch.B,M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Manchester Royal Infirmary


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

October 2009

Completion Date:

October 2011

Related Keywords:

  • Actinic Keratosis
  • Renal transplant patients
  • Actinic Keratoses
  • Metvix PDT
  • Field cancerisation
  • Gene expression
  • Keratosis
  • Keratosis, Actinic