Clinical trial · Interventional
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
NCT01000636CI-TRIAL-00051993completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metvix PDT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metvix PDT
- interventionNames
- Procedure: Metvix PDT
Primary outcomes (1)
- measure
- Percent Change From Baseline in Lesion Count at Week 18
- timeFrame
- Baseline and Week 18.
- description
- Percent Change in Lesion Counts at Week 18: Week 18 count minus Baseline count divided by Baseline count multiplied by 100.
Secondary outcomes (1)
- measure
- Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15
- timeFrame
- Baseline and Month15
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.