Trial Outcomes & Findings for Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients (NCT NCT01532453)
NCT ID: NCT01532453
Last Updated: 2016-01-08
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
244 participants
Primary outcome timeframe
2 Years
Results posted on
2016-01-08
Participant Flow
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.
Participant milestones
| Measure |
Standard Sun Protection Measures
Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
160
|
|
Overall Study
COMPLETED
|
54
|
90
|
|
Overall Study
NOT COMPLETED
|
27
|
70
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
Baseline characteristics by cohort
| Measure |
Standard Sun Protection Measures
n=81 Participants
Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
|
MD-3511356
n=160 Participants
MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.20 years
STANDARD_DEVIATION 9.483 • n=93 Participants
|
62.29 years
STANDARD_DEVIATION 8.875 • n=4 Participants
|
62.59 years
STANDARD_DEVIATION 9.075 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=93 Participants
|
115 Participants
n=4 Participants
|
180 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 YearsPopulation: 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.
Outcome measures
| Measure |
MD-3511356
n=146 Participants
MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
|
Standard Sun Protection Measures
n=74 Participants
Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
|
|---|---|---|
|
Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas
|
9.88 new actinic keratoses or scc
Standard Deviation 15.761
|
11.73 new actinic keratoses or scc
Standard Deviation 14.939
|
SECONDARY outcome
Timeframe: 2 YearsPopulation: 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.
Outcome measures
| Measure |
MD-3511356
n=145 Participants
MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
|
Standard Sun Protection Measures
n=74 Participants
Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
|
|---|---|---|
|
Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas
|
77.2 percentage of patients
|
83.8 percentage of patients
|
Adverse Events
Standard Sun Protection Measures
Serious events: 29 serious events
Other events: 12 other events
Deaths: 0 deaths
MD-3511356
Serious events: 38 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Sun Protection Measures
n=81 participants at risk
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.
|
MD-3511356
n=160 participants at risk
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.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma
|
1.2%
1/81 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Blood and lymphatic system disorders
anemia
|
1.2%
1/81 • Number of events 1
|
1.2%
2/160 • Number of events 2
|
|
Cardiac disorders
atrial fibrillation
|
1.2%
1/81 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Cardiac disorders
myocardial infarction
|
1.2%
1/81 • Number of events 1
|
1.2%
2/160 • Number of events 2
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.00%
0/81
|
1.2%
2/160 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
1.2%
1/81 • Number of events 1
|
1.9%
3/160 • Number of events 3
|
|
General disorders
chest pain
|
1.2%
1/81 • Number of events 1
|
1.2%
2/160 • Number of events 2
|
|
Infections and infestations
biliary sepsis
|
2.5%
2/81 • Number of events 2
|
0.00%
0/160
|
|
Infections and infestations
diverticulitis
|
2.5%
2/81 • Number of events 2
|
0.62%
1/160 • Number of events 1
|
|
Infections and infestations
erysipelas
|
1.2%
1/81 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/81
|
1.9%
3/160 • Number of events 3
|
|
Infections and infestations
gastroenteritis norovirus
|
1.2%
1/81 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Infections and infestations
herpes zoster
|
1.2%
1/81 • Number of events 1
|
1.2%
2/160 • Number of events 2
|
|
Infections and infestations
influenza
|
2.5%
2/81 • Number of events 2
|
0.62%
1/160 • Number of events 1
|
|
Infections and infestations
pneumonia
|
6.2%
5/81 • Number of events 5
|
3.1%
5/160 • Number of events 5
|
|
Infections and infestations
respiratory tract infection
|
2.5%
2/81 • Number of events 2
|
0.00%
0/160
|
|
Infections and infestations
septic shock
|
1.2%
1/81 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Injury, poisoning and procedural complications
complications of transplanted kidney
|
0.00%
0/81
|
1.2%
2/160 • Number of events 2
|
|
Investigations
forced expiratory volume decreased
|
2.5%
2/81 • Number of events 2
|
0.62%
1/160 • Number of events 1
|
|
Metabolism and nutrition disorders
dehydration
|
2.5%
2/81 • Number of events 2
|
0.00%
0/160
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
2.5%
2/81 • Number of events 2
|
0.62%
1/160 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastases to liver
|
0.00%
0/81
|
1.2%
2/160 • Number of events 2
|
|
Nervous system disorders
syncope
|
1.2%
1/81 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
1.2%
1/81 • Number of events 1
|
0.62%
1/160 • Number of events 1
|
|
Vascular disorders
peripheral arterial occlusive disease
|
1.2%
1/81 • Number of events 1
|
1.2%
2/160 • Number of events 2
|
Other adverse events
| Measure |
Standard Sun Protection Measures
n=81 participants at risk
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.
|
MD-3511356
n=160 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
pneumonia
|
6.2%
5/81 • Number of events 5
|
4.4%
7/160 • Number of events 7
|
|
Vascular disorders
hypertension
|
8.6%
7/81 • Number of events 7
|
2.5%
4/160 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER