Not provided
Not provided
Not provided
Not provided
Not provided
For futility reasons and potential "loss of chance" for MD 3511356 group
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of MD 3511356 sunscreen in preventing AK and SCC in post transplant immune-suppressed patients compared to standard of care.
The present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Sun Protection Measures | Active Comparator | 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). |
|
| MD-3511356 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MD-3511356 | Device | Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas | 2 Years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claas Ulrich, MD | Klinikum der Charité Universitätsmedizin, Hauttumorzentrum Charité, D-10117 Berlin/Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Wien | Vienna | Austria | ||||
| Charles University Hospital |
Of 244 patients enrolled, 3 patients were considered screening failures (003-006, 005-002 and 010-027). Patient 003 006 used forbidden concomitant medication. Patient 005 002 had severe sun damage of the skin, violation of exclusion criterion #5. Patient 010 027 was re-enrolled as Patient 010 029 and later randomized to the MD-3511356 group.
Of 244 patients enrolled, 3 patients were considered screening failures (003-006, 005-002 and 010-027). Patient 003 006 used forbidden concomitant medication. Patient 005 002 had severe sun damage of the skin, violation of exclusion criterion #5. Patient 010 027 was re-enrolled as Patient 010 029 and later randomized to the MD-3511356 group.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Sun Protection Measures | Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product. |
| FG001 | MD-3511356 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Sun Protection Measures | Other | Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product. |
|
| Pilsen |
| Czechia |
| Hôpital Edouard | Lyon | France |
| Klinikum der Charité Universitätsmedizin | Berlin | 10117 | Germany |
| Hautklinik am Nationalen Zentrum für Tumorerkrankungen | Heidelberg | Germany |
| Beaumont Hospital | Dublin | Ireland |
| Leiden University Medical Center | Leiden | Netherlands |
| Universitätsspital Zürich, Dermatologische Klinik | Zurich | Switzerland |
| Başkent University Faculty of Medicine | Ankara | Turkey (Türkiye) |
| Queen Mary University of London | London | United Kingdom |
MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Sun Protection Measures | Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product. |
| BG001 | MD-3511356 | MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas | 241 patients were randomized: 160 to the MD 3511356 group and 81 to the standard care group. All 241 randomized patients received at least one dose of trial device and therefore were all included in the safety population. The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group. | Posted | Mean | Standard Deviation | new actinic keratoses or scc | 2 Years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas | The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group. For patient 10018 (MD-3511356 group) the age of first organ transplant was not computable due to missing date. | Posted | Number | percentage of patients | 2 Years |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Sun Protection Measures | 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). Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product. | 29 | 81 | 12 | 81 | ||
| EG001 | MD-3511356 | 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). MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun. | 38 | 160 | 11 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| anemia | Blood and lymphatic system disorders | medDRA | Non-systematic Assessment |
| |
| atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| biliary sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| diverticulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| erysipelas | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| gastroenteritis norovirus | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| herpes zoster | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| influenza | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| septic shock | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| complications of transplanted kidney | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| forced expiratory volume decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| syncope | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| peripheral arterial occlusive disease | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| hypertension | Vascular disorders | medDRA | Non-systematic Assessment |
|
Trial was terminated early for futility reasons (outcome would not be changed, if trial pursued up completion) and potential "loss of chance" (which could neither be confirmed nor rejected at the time) for patients included in the MD 3511356 group.
Investigator is granted a right to publish and present Trial Results together with other investigators of Trial and to be referred to in publications containing such results. However, investigator shall not publish or present Trial Results unless Investigator has submitted to Spirig a draft of the intended publication or presentation for review and approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Francine Santoro | Galderma Spirig | +41 62 387 87 87 | 87 20 | Francine.santoro@galderma.com |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
Not provided
Not provided
| Male |
|
|
|