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Trial record 90 of 272 for:    Betamethasone

Non-interventional Study of Long-term Treatment of Psoriasis With Calcipotriol Plus Betamethasone in Gel Formulation

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ClinicalTrials.gov Identifier: NCT01707368
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Psoriasis Vulgaris
Plaque Psoriasis
Intervention Drug: Daivobet® Gel
Enrollment 561
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title All Eligible Patients
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 561
Completed 393
Not Completed 168
Arm/Group Title All Eligible Patients
Hide Arm/Group Description 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 Number of Baseline Participants 561
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 561 participants
51.05  (16.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 561 participants
Female
283
  50.4%
Male
278
  49.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Germany Number Analyzed 561 participants
561
 100.0%
Affected body surface area (BSA) at admission  
Measure Type: Count of Participants
Unit of measure:  Participants
<2% Number Analyzed 561 participants
45
   8.0%
2-4% Number Analyzed 561 participants
119
  21.2%
4-6% Number Analyzed 561 participants
138
  24.6%
6-8% Number Analyzed 561 participants
125
  22.3%
8-10% Number Analyzed 561 participants
83
  14.8%
>10% Number Analyzed 561 participants
51
   9.1%
1.Primary Outcome
Title The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient`s Individual Application Habits Under Daily Use Conditions.
Hide Description Number of exacerbations and relapses during one year observation time
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one observation after baseline
Arm/Group Title All Eligible Patients
Hide Arm/Group Description:
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 Number of Participants Analyzed 529
Measure Type: Count of Participants
Unit of Measure: Participants
No relapse
277
  52.4%
1 relapse
121
  22.9%
2 relapses
59
  11.2%
3 relapses
24
   4.5%
More than 3 relapses
48
   9.1%
2.Secondary Outcome
Title PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Hide Description 6--point verbal rating scale
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one severity assessment after baseline
Arm/Group Title All Eligible Patients
Hide Arm/Group Description:
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 Number of Participants Analyzed 528
Measure Type: Count of Participants
Unit of Measure: Participants
Free of symptoms
0
   0.0%
Almost free of symptoms
5
   0.9%
Mild
108
  20.5%
Moderate
350
  66.3%
Severe
60
  11.4%
Very severe
5
   0.9%
3.Secondary Outcome
Title PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)
Hide Description Assessment on 6-step scale from "no visible disease (O)" to "very severe disease (5)
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with at least one observation after baseline (last observation carried forward)
Arm/Group Title All Eligible Patients
Hide Arm/Group Description:
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 Number of Participants Analyzed 528
Measure Type: Count of Participants
Unit of Measure: Participants
Free of symptoms
66
  12.5%
Almost free of symptoms
177
  33.5%
Symptoms mild
153
  29.0%
Symptoms moderate
115
  21.8%
Symptoms severe
16
   3.0%
Symptoms very severe
1
   0.2%
4.Secondary Outcome
Title Side Effects
Hide Description Number of participants with serious and non-serious adverse drug reactions.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled
Arm/Group Title All Eligible Patients
Hide Arm/Group Description:
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 Number of Participants Analyzed 561
Measure Type: Number
Unit of Measure: Number of events recorded
Serious with causal relation probable 0
Serious with causal relation possible 0
Serious, not related 2
Serious, causality not assessible 1
Non-serious, causal relation probable 8
Non-serious, causal relation possible 5
Non-serious, not related 17
Non-serious, causality not assessible 29
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Eligible Patients
Hide Arm/Group Description 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.
All-Cause Mortality
All Eligible Patients
Affected / at Risk (%)
Total   2/561 (0.36%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Eligible Patients
Affected / at Risk (%) # Events
Total   3/561 (0.53%)    
General disorders   
Sudden death * 1  1/561 (0.18%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon Cancer * 1  1/561 (0.18%)  1
Skin and subcutaneous tissue disorders   
Psoriasis * 1  1/561 (0.18%)  1
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Eligible Patients
Affected / at Risk (%) # Events
Total   50/561 (8.91%)    
Gastrointestinal disorders   
Abdominal pain * 1  1/561 (0.18%)  1
Abdominal distension * 1  1/561 (0.18%)  1
Nausea * 1  1/561 (0.18%)  1
General disorders   
Drug ineffective * 1  42/561 (7.49%)  42
Sense of oppression * 1  1/561 (0.18%)  1
Application site dryness * 1  1/561 (0.18%)  1
Infections and infestations   
Application site pustules * 1  2/561 (0.36%)  2
Follikulitis * 1  1/561 (0.18%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory distress * 1  1/561 (0.18%)  1
Throat tightness * 1  1/561 (0.18%)  1
Skin and subcutaneous tissue disorders   
Psoriasis * 1  5/561 (0.89%)  5
Rosacea * 1  1/561 (0.18%)  1
Vascular disorders   
Flushing * 1  1/561 (0.18%)  1
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Mean duration of observation per patients: Mean (SD): 40.47 (17.60) weeks.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tobias Anger, Medical Advisor
Organization: LEO Pharma GmbH
Phone: +49 610 220 1258
EMail: TANDE@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01707368     History of Changes
Other Study ID Numbers: DE-Daivobet-longterm-NIS-2012
First Submitted: October 12, 2012
First Posted: October 16, 2012
Results First Submitted: January 24, 2018
Results First Posted: September 24, 2018
Last Update Posted: September 24, 2018