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Trial record 58 of 273 for:    Betamethasone

Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris

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ClinicalTrials.gov Identifier: NCT00670241
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : March 8, 2011
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Interventions Drug: calcipotriol and betamethasone (LEO 80185 gel)
Drug: LEO 80185 vehicle
Drug: Tacalcitol ointment
Enrollment 458
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Hide Arm/Group Description Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks Tacalcitol Ointment for up to 8 weeks Gel Vehicle for up to 8 weeks
Period Title: Overall Study
Started 183 184 91
Completed 171 163 64
Not Completed 12 21 27
Arm/Group Title Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle Total
Hide Arm/Group Description Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks Tacalcitol Ointment for up to 8 weeks Gel Vehicle for up to 8 weeks Total of all reporting groups
Overall Number of Baseline Participants 183 184 91 458
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 184 participants 91 participants 458 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
148
  80.9%
155
  84.2%
74
  81.3%
377
  82.3%
>=65 years
35
  19.1%
29
  15.8%
17
  18.7%
81
  17.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 183 participants 184 participants 91 participants 458 participants
50.9  (14.3) 51.7  (13.4) 52.8  (14.9) 51.6  (14.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 184 participants 91 participants 458 participants
Female
66
  36.1%
69
  37.5%
38
  41.8%
173
  37.8%
Male
117
  63.9%
115
  62.5%
53
  58.2%
285
  62.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 183 participants 184 participants 91 participants 458 participants
183 184 91 458
1.Primary Outcome
Title Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Hide Arm/Group Description:
Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
Tacalcitol Ointment for up to 8 weeks
Gel Vehicle for up to 8 weeks
Overall Number of Participants Analyzed 183 184 91
Measure Type: Number
Unit of Measure: Participants
73 33 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcipotriol Plus Betamethasone Dipropionate Gel, Tacalcitol Ointment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.42
Confidence Interval (2-Sided) 95%
2.05 to 5.70
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Hide Arm/Group Description:
Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
Tacalcitol Ointment for up to 8 weeks
Gel Vehicle for up to 8 weeks
Overall Number of Participants Analyzed 183 184 91
Measure Type: Number
Unit of Measure: participants
34 12 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcipotriol Plus Betamethasone Dipropionate Gel, Tacalcitol Ointment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.51
Confidence Interval (2-Sided) 98.33%
1.46 to 8.40
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Percentage Change in PASI From Baseline to Week 8
Hide Description PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8 (worst).
Time Frame Baseline, Week 4 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Hide Arm/Group Description:
Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
Tacalcitol Ointment for up to 8 weeks
Gel Vehicle for up to 8 weeks
Overall Number of Participants Analyzed 183 184 91
Measure Type: Number
Unit of Measure: Percent change in PASI score
-57.0 -41.9 -17.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Calcipotriol Plus Betamethasone Dipropionate Gel, Tacalcitol Ointment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.7
Confidence Interval (2-Sided) 98.33%
-22.6 to -6.90
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Subjects With Relapse During the Study
Hide Description Among subjects with controlled disease at week 8 relapse was defined as PASI exceeding the baseline PASI value minus 50% of the reduction in PASI obtained from the baseline visit to the last on-treatment visit
Time Frame Week 8-16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Hide Arm/Group Description:
Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
Tacalcitol Ointment for up to 8 weeks
Gel Vehicle for up to 8 weeks
Overall Number of Participants Analyzed 67 31 5
Measure Type: Number
Unit of Measure: participants
28 7 3
5.Secondary Outcome
Title Subjects With Rebound During the Study
Hide Description [Not Specified]
Time Frame Week 8-16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Hide Arm/Group Description:
Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks
Tacalcitol Ointment for up to 8 weeks
Gel Vehicle for up to 8 weeks
Overall Number of Participants Analyzed 67 31 5
Measure Type: Number
Unit of Measure: participants
0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Hide Arm/Group Description Calcipotriol Plus Betamethasone Dipropionate Gel for up to 8 weeks Tacalcitol Ointment for up to 8 weeks Gel Vehicle for up to 8 weeks
All-Cause Mortality
Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/182 (0.00%)   4/184 (2.17%)   1/91 (1.10%) 
Cardiac disorders       
Arrhythmia * 1  0/182 (0.00%)  1/184 (0.54%)  0/91 (0.00%) 
Myocardial infarction * 1  0/182 (0.00%)  0/184 (0.00%)  1/91 (1.10%) 
Infections and infestations       
Gastroenteritis * 1  0/182 (0.00%)  1/184 (0.54%)  0/91 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Squamous cell carcinoma * 1  0/182 (0.00%)  1/184 (0.54%)  0/91 (0.00%) 
Reproductive system and breast disorders       
Cervical dysplasia * 1  0/182 (0.00%)  1/184 (0.54%)  0/91 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Calcipotriol Plus Betamethasone Dipropionate Gel Tacalcitol Ointment Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/182 (13.74%)   28/184 (15.22%)   10/91 (10.99%) 
Infections and infestations       
Nasopharyngitis * 1  11/182 (6.04%)  6/184 (3.26%)  1/91 (1.10%) 
Upper respiratory tract infection * 1  8/182 (4.40%)  10/184 (5.43%)  2/91 (2.20%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  6/182 (3.30%)  13/184 (7.07%)  7/91 (7.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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: Anders Rhod Larsen, Scientific Advisor
Organization: LEO Pharma
Phone: +4572262990
EMail: anders.larsen@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT00670241     History of Changes
Other Study ID Numbers: LEO 80185-G21
First Submitted: April 29, 2008
First Posted: May 1, 2008
Results First Submitted: November 23, 2010
Results First Posted: March 8, 2011
Last Update Posted: April 14, 2015