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LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

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ClinicalTrials.gov Identifier: NCT01188928
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : April 9, 2013
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Interventions Drug: Calcipotriol plus betamethasone
Drug: Betamethasone-17,21-dipropionate
Drug: Calcipotriene
Drug: Topical suspension vehicle
Enrollment 1152
Recruitment Details The first subject’s first visit was on 27-SEP-2010 and the last subject’s last visit was on 29-MAR-2011. Hence the study had a duration of 26 weeks.
Pre-assignment Details  
Arm/Group Title LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle
Hide Arm/Group Description Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle Calcipotriol 50 mcg/g in the topical suspension vehicle The topical suspension vehicle alone
Period Title: Overall Study
Started 482 479 96 95
Completed 444 417 82 77
Not Completed 38 62 14 18
Arm/Group Title LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle Total
Hide Arm/Group Description Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle Calcipotriol 50 mcg/g in the topical suspension vehicle The topical suspension vehicle alone Total of all reporting groups
Overall Number of Baseline Participants 482 479 96 95 1152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 482 participants 479 participants 96 participants 95 participants 1152 participants
48.7  (13.4) 48.5  (13.8) 48  (13.7) 49.4  (13.0) 48.6  (13.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 482 participants 479 participants 96 participants 95 participants 1152 participants
Female
198
  41.1%
193
  40.3%
36
  37.5%
35
  36.8%
462
  40.1%
Male
284
  58.9%
286
  59.7%
60
  62.5%
60
  63.2%
690
  59.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 482 participants 479 participants 96 participants 95 participants 1152 participants
482 479 96 95 1152
1.Primary Outcome
Title Controlled Disease According to the Investigator’s Global Assessment of Disease Severity (IGA) at Weeks 4
Hide Description The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with ‘Controlled disease’ according to the IGA. ‘Controlled disease’ is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle
Hide Arm/Group Description:
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
Calcipotriol 50 mcg/g in the topical suspension vehicle
The topical suspension vehicle alone
Overall Number of Participants Analyzed 482 479 96 95
Measure Type: Number
Unit of Measure: participants
64 60 5 2
2.Primary Outcome
Title Controlled Disease According to the Investigator’s Global Assessment of Disease Severity (IGA) at Weeks 8
Hide Description The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with ‘Controlled disease’ according to the IGA. ‘Controlled disease’ is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.
Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle
Hide Arm/Group Description:
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
Calcipotriol 50 mcg/g in the topical suspension vehicle
The topical suspension vehicle alone
Overall Number of Participants Analyzed 482 479 96 95
Measure Type: Number
Unit of Measure: participants
140 103 14 6
3.Secondary Outcome
Title Mean Percentage Change in PASI From Baseline to Week 4
Hide Description At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject’s psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle
Hide Arm/Group Description:
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
Calcipotriol 50 mcg/g in the topical suspension vehicle
The topical suspension vehicle alone
Overall Number of Participants Analyzed 482 479 96 95
Mean (Standard Deviation)
Unit of Measure: percentage of change in PASI
-46.4  (30.2) -42.7  (29.4) -32.2  (27.3) -17.4  (36.8)
4.Secondary Outcome
Title Mean Percentage Change in PASI From Baseline to Week 8
Hide Description At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject’s psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.
Time Frame Baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle
Hide Arm/Group Description:
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
Calcipotriol 50 mcg/g in the topical suspension vehicle
The topical suspension vehicle alone
Overall Number of Participants Analyzed 482 479 96 95
Mean (Standard Deviation)
Unit of Measure: percentage of change in PASI
-55.8  (34.4) -48.6  (35.8) -43.6  (34.1) -20.9  (49.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle
Hide Arm/Group Description Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle Calcipotriol 50 mcg/g in the topical suspension vehicle The topical suspension vehicle alone
All-Cause Mortality
LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/482 (0.21%)      7/479 (1.46%)      0/96 (0.00%)      1/95 (1.05%)    
Hepatobiliary disorders         
Cholecystitis acute  0/482 (0.00%)  0 1/479 (0.21%)  1 0/96 (0.00%)  0 0/95 (0.00%)  0
Infections and infestations         
Cellulitis  0/482 (0.00%)  0 1/479 (0.21%)  1 0/96 (0.00%)  0 0/95 (0.00%)  0
Injury, poisoning and procedural complications         
Alcohol poisoning  0/482 (0.00%)  0 1/479 (0.21%)  1 0/96 (0.00%)  0 0/95 (0.00%)  0
Psychiatric disorders         
Suicidal ideation  0/482 (0.00%)  0 1/479 (0.21%)  1 0/96 (0.00%)  0 0/95 (0.00%)  0
Suicide attempt  0/482 (0.00%)  0 0/479 (0.00%)  0 0/96 (0.00%)  0 1/95 (1.05%)  1
Renal and urinary disorders         
Haematuria  0/482 (0.00%)  0 1/479 (0.21%)  1 0/96 (0.00%)  0 0/95 (0.00%)  0
Nephrolithiasis  0/482 (0.00%)  0 1/479 (0.21%)  1 0/96 (0.00%)  0 0/95 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  0/482 (0.00%)  0 1/479 (0.21%)  1 0/96 (0.00%)  0 0/95 (0.00%)  0
Surgical and medical procedures         
Stent placement  0/482 (0.00%)  0 1/479 (0.21%)  1 0/96 (0.00%)  0 0/95 (0.00%)  0
Vascular disorders         
Hypertension  1/482 (0.21%)  1 0/479 (0.00%)  0 0/96 (0.00%)  0 0/95 (0.00%)  0
1
Term from vocabulary, MedDRA 13.00
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LEO 80185 Betamethasone Calcipotriol Topical Suspension Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/482 (2.90%)      15/479 (3.13%)      5/96 (5.21%)      3/95 (3.16%)    
Infections and infestations         
Nasopharyngitis * 1  14/482 (2.90%)  15/479 (3.13%)  5/96 (5.21%)  3/95 (3.16%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.00
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Prior to submitting or presenting a manuscript relating to the clinical trial to a publisher, reviewer, or other outside person, the Investigator shall provide to LEO a copy of all such manuscripts, and LEO shall have rights to review and comment. Upon the request of LEO the Investigator shall remove any confidential information (other than results generated by the Investigator) prior to submitting or presenting the manuscripts.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosure Manager
Organization: Leo Pharma A/S
Phone: +45 4494 5888
EMail: disclosure@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01188928     History of Changes
Other Study ID Numbers: LEO 80185-G23
First Submitted: August 25, 2010
First Posted: August 26, 2010
Results First Submitted: January 21, 2013
Results First Posted: April 9, 2013
Last Update Posted: February 2, 2017