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
  Purpose

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 Intervention Phase
Actinic Keratosis
Procedure: Metvix PDT
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Name: Metvix PDT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000636

Locations
United Kingdom
Department of Dermatology of Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: John T. Lear, MB,Ch.B,M.D Manchester Royal Infirmary
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01000636     History of Changes
Other Study ID Numbers: RD.03.SPR.29061, Eudract # :2008-001603-30
Study First Received: October 22, 2009
Last Updated: February 23, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Galderma:
Renal transplant patients
Actinic Keratoses
Metvix PDT
Field cancerisation
Gene expression

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Methyl 5-aminolevulinate
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 18, 2014