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LEO 90105 Ointment in Japanese Subjects With Psoriasis

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ClinicalTrials.gov Identifier: NCT01422434
Recruitment Status : Completed
First Posted : August 24, 2011
Results First Posted : March 11, 2014
Last Update Posted : April 14, 2015
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Drug: LEO 90105 = calcipotriol + betamethasone dipropionate
Drug: Dovonex® = calcipotriol
Drug: Rinderon® - DP = betamethasone dipropionate
Enrollment 676
Recruitment Details First Subject First Visit: 06-Aug-2011 Last Subject Last Visit: 28-May-2012
Pre-assignment Details Prior to randomisation at Visit 1 (Day 0), a washout period of up to maximum 4 weeks was completed if the subject was/had been treated with anti-psoriatic treatments or other relevant medication, as defined by the exclusion criteria
Arm/Group Title Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment (Betamethasone Dipropionate)
Hide Arm/Group Description

Applied twice daily for 4 weeks.

Dovonex® = calcipotriol : Applied twice daily for 4 weeks.

LEO 90105 ointment applied once daily for 4 weeks.

LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.

Applied once daily for 4 weeks

Rinderon® - DP ointment ( betamethasone dipropionate) : Applied once daily for 4 weeks.

Period Title: Overall Study
Started 227 226 223
Completed 216 221 217
Not Completed 11 5 6
Arm/Group Title Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment Total
Hide Arm/Group Description

Applied twice daily for 4 weeks.

Dovonex® = calcipotriol : Applied twice daily for 4 weeks.

LEO 90105 ointment applied once daily for 4 weeks.

LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.

Applied once daily for 4 weeks

Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 227 226 223 676
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 227 participants 226 participants 223 participants 676 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
158
  69.6%
155
  68.6%
163
  73.1%
476
  70.4%
>=65 years
69
  30.4%
71
  31.4%
60
  26.9%
200
  29.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 227 participants 226 participants 223 participants 676 participants
53.9  (15.4) 54.9  (15.5) 53.7  (15.6) 54.2  (15.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 227 participants 226 participants 223 participants 676 participants
Female
66
  29.1%
67
  29.6%
54
  24.2%
187
  27.7%
Male
161
  70.9%
159
  70.4%
169
  75.8%
489
  72.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 227 participants 226 participants 223 participants 676 participants
227 226 223 676
1.Primary Outcome
Title Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)
Hide Description

The primary response criterion was the percentage change in m-PASI from baseline to Week 4.

The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula:

Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8.

Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment
Hide Arm/Group Description:

Applied twice daily for 4 weeks.

Dovonex® = calcipotriol : Applied twice daily for 4 weeks.

LEO 90105 ointment applied once daily for 4 weeks.

LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.

Applied once daily for 4 weeks

Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.

Overall Number of Participants Analyzed 227 226 223
Mean (Standard Deviation)
Unit of Measure: percentage of change
-50.5  (32.1) -64.3  (24.7) -53.6  (26.4)
2.Secondary Outcome
Title Change From Baseline in Target Lesion Assessment
Hide Description

Percentage change in composite severity score of the target lesion from baseline to Week 4.

At Visit 1, the investigator selected a target lesion. Location was recorded as trunk, limb excluding elbow and/or knee.

At Visits 1-4, the investigator assessed the severity of the target lesion for each sign (redness, thickness and scaliness) on a scale from 0 to 8 where 0 is no signs of redness, thickness or scaliness and 8 is the most severe signs of redness, thickeness or scaliniess.

The individual scores for redness, thickness and scaliness were added together to give a single composite score for severity of the target lesion which could range from 0 to 24. The percentage change in the composite severity score from baseline to each visit was also calcutated.

Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment
Hide Arm/Group Description:

Applied twice daily for 4 weeks.

Dovonex® = calcipotriol : Applied twice daily for 4 weeks.

LEO 90105 ointment applied once daily for 4 weeks.

LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.

Applied once daily for 4 weeks

Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.

Overall Number of Participants Analyzed 227 226 223
Mean (Standard Deviation)
Unit of Measure: percentage of change
-57.1  (27.6) -70.5  (21.1) -58.6  (26.1)
3.Secondary Outcome
Title Physician's Global Assessment of Psoriasis
Hide Description

Subjects with ‘clear’ or ‘almost clear’ disease by physician’s global assessment on the following 6 point scale: clear, almost clear, mild, moderate, severe, very severe.

The assessment represents the average lesion severity on the trunk and limbs. The assessment was based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment
Hide Arm/Group Description:

Applied twice daily for 4 weeks.

Dovonex® = calcipotriol : Applied twice daily for 4 weeks.

LEO 90105 ointment applied once daily for 4 weeks.

LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.

Applied once daily for 4 weeks

Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.

Overall Number of Participants Analyzed 227 226 223
Measure Type: Number
Unit of Measure: participants
52 89 43
4.Secondary Outcome
Title Change in mPASI From Baseline to Week 1
Hide Description The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI. The m-PASI could range from 0 to 64.8. The least severe outcome is 0 and the most severe outcome is 64.8
Time Frame Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment
Hide Arm/Group Description:

Applied twice daily for 4 weeks.

Dovonex® = calcipotriol : Applied twice daily for 4 weeks.

LEO 90105 ointment applied once daily for 4 weeks.

LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.

Applied once daily for 4 weeks

Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.

Overall Number of Participants Analyzed 227 226 223
Mean (Standard Deviation)
Unit of Measure: percentage of change
-23.7  (23.0) -39.1  (21.8) -29.5  (21.4)
Time Frame [Not Specified]
Adverse Event Reporting Description

Three Serious Adverse Events occoured in subjects not randomized to study treatment:

Adverse event term: Laceration, Radius fracture, Ulna fracture,

Number of participants at risk in the 'dovonex ointment arm' is not conistent with number in the participant flow module as the AE analysis was done on safety set, not on randomised set.

 
Arm/Group Title Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment
Hide Arm/Group Description

Applied twice daily for 4 weeks.

Dovonex® = calcipotriol : Applied twice daily for 4 weeks.

LEO 90105 ointment applied once daily for 4 weeks.

LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.

Applied once daily for 4 weeks

Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.

All-Cause Mortality
Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/226 (0.44%)      2/226 (0.88%)      1/223 (0.45%)    
Cardiac disorders       
Acute coronary syndrome * 1  0/226 (0.00%)  0 1/226 (0.44%)  1 0/223 (0.00%)  0
Gastrointestinal disorders       
Intestinal obstruction * 1  0/226 (0.00%)  0 0/226 (0.00%)  0 1/223 (0.45%)  1
Injury, poisoning and procedural complications       
Injury * 1  0/226 (0.00%)  0 1/226 (0.44%)  1 0/223 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer * 1  1/226 (0.44%)  1 0/226 (0.00%)  0 0/223 (0.00%)  0
Renal and urinary disorders       
Calculus urinary * 1  0/226 (0.00%)  0 1/226 (0.44%)  1 0/223 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dovonex® Ointment LEO 90105 Ointment Rinderon® - DP Ointment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/226 (11.95%)      20/226 (8.85%)      16/223 (7.17%)    
Infections and infestations       
Nasopharyngitis * 1  13/226 (5.75%)  14 15/226 (6.64%)  16 12/223 (5.38%)  14
Skin and subcutaneous tissue disorders       
Psoriasis * 1  14/226 (6.19%)  14 5/226 (2.21%)  7 4/223 (1.79%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical trial disclosure manager
Organization: LEO Pharma A/S
Phone: 00 45 44 94 58 88
EMail: ctr.disclosure@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01422434     History of Changes
Other Study ID Numbers: MCB 0903
First Submitted: August 15, 2011
First Posted: August 24, 2011
Results First Submitted: September 24, 2013
Results First Posted: March 11, 2014
Last Update Posted: April 14, 2015