Trial Outcomes & Findings for LEO 90105 Ointment in Japanese Subjects With Psoriasis (NCT NCT01422434)
NCT ID: NCT01422434
Last Updated: 2025-03-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
676 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2025-03-12
Participant Flow
First Subject First Visit: 06-Aug-2011 Last Subject Last Visit: 28-May-2012
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
Participant milestones
| Measure |
Dovonex® Ointment
Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks.
|
LEO 90105 Ointment
LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.
|
Rinderon® - DP Ointment (Betamethasone Dipropionate)
Applied once daily for 4 weeks
Rinderon® - DP ointment ( betamethasone dipropionate) : Applied once daily for 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
227
|
226
|
223
|
|
Overall Study
COMPLETED
|
216
|
221
|
217
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LEO 90105 Ointment in Japanese Subjects With Psoriasis
Baseline characteristics by cohort
| Measure |
Dovonex® Ointment
n=227 Participants
Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks.
|
LEO 90105 Ointment
n=226 Participants
LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.
|
Rinderon® - DP Ointment
n=223 Participants
Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.
|
Total
n=676 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
158 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
476 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 15.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
187 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
489 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
227 participants
n=5 Participants
|
226 participants
n=7 Participants
|
223 participants
n=5 Participants
|
676 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4The 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.
Outcome measures
| Measure |
Dovonex® Ointment
n=227 Participants
Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks.
|
LEO 90105 Ointment
n=226 Participants
LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.
|
Rinderon® - DP Ointment
n=223 Participants
Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.
|
|---|---|---|---|
|
Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)
|
-50.5 percentage of change
Standard Deviation 32.1
|
-64.3 percentage of change
Standard Deviation 24.7
|
-53.6 percentage of change
Standard Deviation 26.4
|
SECONDARY outcome
Timeframe: Baseline to Week 4Percentage 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.
Outcome measures
| Measure |
Dovonex® Ointment
n=227 Participants
Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks.
|
LEO 90105 Ointment
n=226 Participants
LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.
|
Rinderon® - DP Ointment
n=223 Participants
Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.
|
|---|---|---|---|
|
Change From Baseline in Target Lesion Assessment
|
-57.1 percentage of change
Standard Deviation 27.6
|
-70.5 percentage of change
Standard Deviation 21.1
|
-58.6 percentage of change
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: Week 4Subjects 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.
Outcome measures
| Measure |
Dovonex® Ointment
n=227 Participants
Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks.
|
LEO 90105 Ointment
n=226 Participants
LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.
|
Rinderon® - DP Ointment
n=223 Participants
Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.
|
|---|---|---|---|
|
Physician's Global Assessment of Psoriasis
|
52 participants
|
89 participants
|
43 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 1The 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
Outcome measures
| Measure |
Dovonex® Ointment
n=227 Participants
Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks.
|
LEO 90105 Ointment
n=226 Participants
LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.
|
Rinderon® - DP Ointment
n=223 Participants
Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.
|
|---|---|---|---|
|
Change in mPASI From Baseline to Week 1
|
-23.7 percentage of change
Standard Deviation 23.0
|
-39.1 percentage of change
Standard Deviation 21.8
|
-29.5 percentage of change
Standard Deviation 21.4
|
Adverse Events
Dovonex® Ointment
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
LEO 90105 Ointment
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Rinderon® - DP Ointment
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dovonex® Ointment
n=226 participants at risk
Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks.
|
LEO 90105 Ointment
n=226 participants at risk
LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.
|
Rinderon® - DP Ointment
n=223 participants at risk
Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/226
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.
|
0.44%
1/226 • Number of events 1
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.
|
0.00%
0/223
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.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/226
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.
|
0.44%
1/226 • Number of events 1
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.
|
0.00%
0/223
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.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/226
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.
|
0.44%
1/226 • Number of events 1
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.
|
0.00%
0/223
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.44%
1/226 • Number of events 1
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.
|
0.00%
0/226
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.
|
0.00%
0/223
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.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/226
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.
|
0.00%
0/226
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.
|
0.45%
1/223 • Number of events 1
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.
|
Other adverse events
| Measure |
Dovonex® Ointment
n=226 participants at risk
Applied twice daily for 4 weeks.
Dovonex® = calcipotriol : Applied twice daily for 4 weeks.
|
LEO 90105 Ointment
n=226 participants at risk
LEO 90105 ointment applied once daily for 4 weeks.
LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks.
|
Rinderon® - DP Ointment
n=223 participants at risk
Applied once daily for 4 weeks
Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.8%
13/226 • Number of events 14
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.
|
6.6%
15/226 • Number of events 16
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.
|
5.4%
12/223 • Number of events 14
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.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
6.2%
14/226 • Number of events 14
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.
|
2.2%
5/226 • Number of events 7
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.
|
1.8%
4/223 • Number of events 4
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER