Clinical trial · Interventional
Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations
NCT01532453CI-TRIAL-00020465terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): For futility reasons and potential "loss of chance" for MD 3511356 group
Summary
Brief summary (as posted)
The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.
Conditions
Conditions (2)
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 Keratoses | — | UNRESOLVED | — |
| Squamous Cell Carcinomas | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MD-3511356 | Device | — | UNRESOLVED |
| Standard Sun Protection Measures | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Sun Protection Measures
- description
- Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).
- interventionNames
- Other: Standard Sun Protection Measures
- type
- EXPERIMENTAL
- label
- MD-3511356
- description
- Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).
- interventionNames
- Device: MD-3511356
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Out-Patients of either sex aged ≥ 40 years * Life-expectancy of 2 years at minimum * Solid organ-transplant recipients who received a kidney (including pancreas), liver, lung, or heart transplant * Patients treated for 5 years with an immunosuppressant medication * Severe sun damage of the skin * Multiple actinic keratoses (2-5 lesions) and/or multiple dysplastic naevi * No present squamous cell carcinoma, basal cell carcinoma or malignant melanoma; but history of cutaneous/cutaneous invasive malignancy with restitutio ad integrum is allowed * Patients who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ICH GCP Exclusion Criteria: * Non-Caucasian * Absence of sun damage i.e. no signs of AK * Multi-organ transplantation (exception: simultaneous transplantation of kidney and pancreas) * Evidence of systemic infection, except viral hepatitis, at the time of recruitment * Known or supposed systemic malignant tumour or systemic chemotherapy within the last 5 years prior to randomisation * Patients participating in a clinical trial within the last four weeks before trial * Patients treated with the antitumour/antiangiogenetic immunosuppressant sirolimus, respectively everolimus, or acitretin or any other systemic treatment for AK at the time of randomisation * Patients treated with a topical drug for the AK at the time of randomisation (exception: excision or Cryotherapy for hyperkeratotic lesions are allowed) * Change of the immunosuppression-treatment less than 3 months ago or planned * Present or planned interferon therapy (in liver transplant patients with hepatitis B/C) * Female patients with childbearing potential with a positive pregnancy test, breast feeding, or female patients with childbearing potential without adequate contraception
References
Publications (0)
Data not yet available
No reference posted for this study.