Trial Outcomes & Findings for Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation (NCT NCT01707368)
NCT ID: NCT01707368
Last Updated: 2018-09-24
Results Overview
Number of exacerbations and relapses during one year observation time
Recruitment status
COMPLETED
Target enrollment
561 participants
Primary outcome timeframe
1 year
Results posted on
2018-09-24
Participant Flow
The study was conducted in Germany between 8th September 2011 (retrospective data) and 15th May 2014. The planned observation period for each patient was about 12 months. The total planned sample size of this NIS was 1000 (analysable 750) patients.
Participant milestones
| Measure |
All Eligible Patients
Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
|
|---|---|
|
Overall Study
STARTED
|
561
|
|
Overall Study
COMPLETED
|
393
|
|
Overall Study
NOT COMPLETED
|
168
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Eligible Patients
n=561 Participants
Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
|
|---|---|
|
Age, Continuous
|
51.05 years
STANDARD_DEVIATION 16.10 • n=561 Participants
|
|
Sex: Female, Male
Female
|
283 Participants
n=561 Participants
|
|
Sex: Female, Male
Male
|
278 Participants
n=561 Participants
|
|
Region of Enrollment
Germany
|
561 Participants
n=561 Participants
|
|
Affected body surface area (BSA) at admission
<2%
|
45 Participants
n=561 Participants
|
|
Affected body surface area (BSA) at admission
2-4%
|
119 Participants
n=561 Participants
|
|
Affected body surface area (BSA) at admission
4-6%
|
138 Participants
n=561 Participants
|
|
Affected body surface area (BSA) at admission
6-8%
|
125 Participants
n=561 Participants
|
|
Affected body surface area (BSA) at admission
8-10%
|
83 Participants
n=561 Participants
|
|
Affected body surface area (BSA) at admission
>10%
|
51 Participants
n=561 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Participants with at least one observation after baseline
Number of exacerbations and relapses during one year observation time
Outcome measures
| Measure |
All Eligible Patients
n=529 Participants
Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
|
|---|---|
|
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.
No relapse
|
277 Participants
|
|
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.
1 relapse
|
121 Participants
|
|
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.
2 relapses
|
59 Participants
|
|
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.
3 relapses
|
24 Participants
|
|
The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient's Individual Application Habits Under Daily Use Conditions.
More than 3 relapses
|
48 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants with at least one severity assessment after baseline
6--point verbal rating scale
Outcome measures
| Measure |
All Eligible Patients
n=528 Participants
Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
|
|---|---|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Free of symptoms
|
0 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Almost free of symptoms
|
5 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Mild
|
108 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Moderate
|
350 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Severe
|
60 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Very severe
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants with at least one observation after baseline (last observation carried forward)
Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5)
Outcome measures
| Measure |
All Eligible Patients
n=528 Participants
Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
|
|---|---|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Free of symptoms
|
66 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Almost free of symptoms
|
177 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Symptoms mild
|
153 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Symptoms moderate
|
115 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Symptoms severe
|
16 Participants
|
|
PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Symptoms very severe
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All enrolled
Number of participants with serious and non-serious adverse drug reactions.
Outcome measures
| Measure |
All Eligible Patients
n=561 Participants
Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
|
|---|---|
|
Side Effects
Serious with causal relation probable
|
0 Number of events recorded
|
|
Side Effects
Serious with causal relation possible
|
0 Number of events recorded
|
|
Side Effects
Serious, not related
|
2 Number of events recorded
|
|
Side Effects
Serious, causality not assessible
|
1 Number of events recorded
|
|
Side Effects
Non-serious, causal relation probable
|
8 Number of events recorded
|
|
Side Effects
Non-serious, causal relation possible
|
5 Number of events recorded
|
|
Side Effects
Non-serious, not related
|
17 Number of events recorded
|
|
Side Effects
Non-serious, causality not assessible
|
29 Number of events recorded
|
Adverse Events
All Eligible Patients
Serious events: 3 serious events
Other events: 50 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
All Eligible Patients
n=561 participants at risk
Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
General disorders
Sudden death
|
0.18%
1/561 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
All Eligible Patients
n=561 participants at risk
Daivobet® Gel once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
|
|---|---|
|
General disorders
Drug ineffective
|
7.5%
42/561 • Number of events 42 • 1 year
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.89%
5/561 • Number of events 5 • 1 year
|
|
Infections and infestations
Application site pustules
|
0.36%
2/561 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
General disorders
Sense of oppression
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
Infections and infestations
Follikulitis
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
Vascular disorders
Flushing
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
General disorders
Application site dryness
|
0.18%
1/561 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.18%
1/561 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place