Status:
COMPLETED
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® Photodynamic Therapy (PDT)
Lead Sponsor:
Galderma R&D
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 cancerise...
Detailed Description
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 pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01000636
Start Date
October 1 2009
End Date
October 1 2011
Last Update
May 26 2021
Active Locations (1)
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1
Department of Dermatology of Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL