Trial Outcomes & Findings for Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris (NCT NCT00764751)
NCT ID: NCT00764751
Last Updated: 2025-03-07
Results Overview
The following formula was used to calculate the PASI for each side of the body: Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z where: R = score for redness T = score for thickness S = score for scaliness E = score for extent The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
From baseline (Day 0) to end of treatment (Day 28)
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
Group A
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
* Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
* LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
12
|
|
Overall Study
COMPLETED
|
37
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group A
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
* Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
* LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Psoriasis flare up on the scalp
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of LEO 19123 Cream in the Treatment of Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
Group A
n=39 Participants
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
* Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B
n=12 Participants
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
* LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
57.7 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
39 participants
n=5 Participants
|
12 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline (Day 0) to end of treatment (Day 28)The following formula was used to calculate the PASI for each side of the body: Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z where: R = score for redness T = score for thickness S = score for scaliness E = score for extent The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here.
Outcome measures
| Measure |
Group A: LEO 19123
n=39 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
|
Group A: Dovonex®
n=39 Participants
Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B: LEO 19123
n=12 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
|
Group B: LEO 19123 Vehicle
n=12 Participants
LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|---|---|
|
The Percentage Change in PASI (Psoriasis Area Severity Index)
|
-24.8 percentage change in PASI
Standard Deviation 33.2
|
-40.2 percentage change in PASI
Standard Deviation 27.8
|
-46.8 percentage change in PASI
Standard Deviation 27.0
|
-29.8 percentage change in PASI
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: At end of treatment (Day 28)At all visits the (sub)investigator made a global assessment of the disease severity for psoriasis on the left and right side, respectively, of the body by use of the 6-point scale below. These assessments were to represent the average lesion severity on the left and right side, respectively. These assessments were to be based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit. Clear Almost clear Mild Moderate Severe Very severe
Outcome measures
| Measure |
Group A: LEO 19123
n=39 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
|
Group A: Dovonex®
n=39 Participants
Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B: LEO 19123
n=12 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
|
Group B: LEO 19123 Vehicle
n=12 Participants
LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|---|---|
|
Investigator's Global Assessment of Disease Severity
Clear
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Investigator's Global Assessment of Disease Severity
Almost clear
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Investigator's Global Assessment of Disease Severity
Mild
|
8 Participants
|
17 Participants
|
3 Participants
|
5 Participants
|
|
Investigator's Global Assessment of Disease Severity
Moderate
|
24 Participants
|
20 Participants
|
5 Participants
|
5 Participants
|
|
Investigator's Global Assessment of Disease Severity
Severe
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Investigator's Global Assessment of Disease Severity
Very severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (Day 28)For subjects with a baseline (Visit 1) severity of moderate or worse, "controlled disease" is defined as "clear" or "almost clear" according to the Investigator's global assessment of disease severity. For subjects with a baseline (Visit 1) severity of mild, "controlled disease" is defined as "clear" according to the Investigator's global assessment of disease severity.
Outcome measures
| Measure |
Group A: LEO 19123
n=39 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
|
Group A: Dovonex®
n=39 Participants
Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B: LEO 19123
n=12 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
|
Group B: LEO 19123 Vehicle
n=12 Participants
LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|---|---|
|
Participants With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity
Controlled disease
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Participants With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity
No controlled disease
|
37 Participants
|
38 Participants
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (Day 28)Population: All randomized participants have been included in the analysis. One participant withdrew and did therefore not give their assessment.
The participant assessed the treatment response by use of the 6-point scale below. Worse Unchanged Slight improvement Moderate improvement Marked improvement Almost clear Cleared
Outcome measures
| Measure |
Group A: LEO 19123
n=39 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
|
Group A: Dovonex®
n=39 Participants
Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B: LEO 19123
n=12 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
|
Group B: LEO 19123 Vehicle
n=12 Participants
LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|---|---|
|
Participant's Overall Assessment of Treatment Response
Worse
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Participant's Overall Assessment of Treatment Response
Unchanged
|
9 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Participant's Overall Assessment of Treatment Response
Slight improvement
|
12 Participants
|
9 Participants
|
1 Participants
|
7 Participants
|
|
Participant's Overall Assessment of Treatment Response
Moderate improvement
|
12 Participants
|
12 Participants
|
5 Participants
|
1 Participants
|
|
Participant's Overall Assessment of Treatment Response
Marked improvement
|
3 Participants
|
12 Participants
|
2 Participants
|
1 Participants
|
|
Participant's Overall Assessment of Treatment Response
Almost clear
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participant's Overall Assessment of Treatment Response
Clear
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (Day 28)Population: All randomized participants have been included in the analysis. One participant withdrew and did therefore not give their preference.
Outcome measures
| Measure |
Group A: LEO 19123
n=39 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
|
Group A: Dovonex®
n=12 Participants
Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B: LEO 19123
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
|
Group B: LEO 19123 Vehicle
LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|---|---|
|
Participant's Assessment of Treatment Preference
LEO 19123
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Participant's Assessment of Treatment Preference
No preference
|
12 Participants
|
3 Participants
|
—
|
—
|
|
Participant's Assessment of Treatment Preference
Reference product
|
21 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline (Day 0) to end of treatment (Day 28)Population: Two participants withdrew from the LEO 19123 versus Dovonex® group at Week 2.
Outcome measures
| Measure |
Group A: LEO 19123
n=39 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
|
Group A: Dovonex®
n=39 Participants
Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B: LEO 19123
n=12 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
|
Group B: LEO 19123 Vehicle
n=12 Participants
LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|---|---|
|
Participants With at Least 75% Reduction in PASI (PASI 75)
>=75% PASI reduction
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Participants With at Least 75% Reduction in PASI (PASI 75)
75% PASI reduction
|
37 Participants
|
35 Participants
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From baseline (Day 0) to end of treatment (day 28)Population: All randomised participants have been included in the analysis.
Outcome measures
| Measure |
Group A: LEO 19123
n=39 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
|
Group A: Dovonex®
n=39 Participants
Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B: LEO 19123
n=12 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
|
Group B: LEO 19123 Vehicle
n=12 Participants
LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|---|---|
|
Participants With at Least 50% Reduction in PASI (PASI 50)
>= 50% PASI reduction
|
9 Participants
|
15 Participants
|
7 Participants
|
2 Participants
|
|
Participants With at Least 50% Reduction in PASI (PASI 50)
< 50% PASI reduction
|
30 Participants
|
24 Participants
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From baseline to end of treatment (Day 28)The following formula was used to calculate the PASI for each side of the body: Upper extremities: 0.2 (R + T+ S) E = X Trunk: 0.3 (R + T+ S) E = Y Lower extremities 0.4 (R + T+ S) E = Z where: R = score for redness T = score for thickness S = score for scaliness E = score for extent The sum of X + Y + Z gives the total PASI, which can range from 0 to 64.8. The PASI used in this study is modified to exclude assessment of the head, as study treatment was not used here.
Outcome measures
| Measure |
Group A: LEO 19123
n=39 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
|
Group A: Dovonex®
n=39 Participants
Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B: LEO 19123
n=12 Participants
LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
|
Group B: LEO 19123 Vehicle
n=12 Participants
LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|---|---|
|
The Absolute Change in PASI (Psoriasis Area Severity Index)
|
-2.6 units on a scale
Standard Deviation 4.0
|
-3.8 units on a scale
Standard Deviation 3.6
|
-4.2 units on a scale
Standard Deviation 2.9
|
-2.5 units on a scale
Standard Deviation 2.1
|
Adverse Events
Group A
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=38 participants at risk
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
* Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B
n=12 participants at risk
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
* LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
Other adverse events
| Measure |
Group A
n=38 participants at risk
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week
* Dovonex® (calcipotriol 50 mcg/g) cream for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
Group B
n=12 participants at risk
* LEO 19123 (calcipotriol 50 mcg/g plus LEO 80122 0.6 mg/g) cream for topical application once daily in the evening to lesions on one side of the body. Maximum 50 g/week.
* LEO 19123 cream vehicle for topical application twice daily to the lesions on the other side of the body. Maximum 50 g/week.
|
|---|---|---|
|
Cardiac disorders
Ventricular extrasystoles
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/38 • From Day 0 to follow up (Day 28+14)
|
8.3%
1/12 • From Day 0 to follow up (Day 28+14)
|
|
General disorders
Pain
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/38 • From Day 0 to follow up (Day 28+14)
|
8.3%
1/12 • From Day 0 to follow up (Day 28+14)
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
3/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Infections and infestations
Pharyngitis
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Infections and infestations
Sinusitis
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
8.3%
1/12 • From Day 0 to follow up (Day 28+14)
|
|
Injury, poisoning and procedural complications
Back injury
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Investigations
Blood glucose increased
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Investigations
Blood potassium increased
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/38 • From Day 0 to follow up (Day 28+14)
|
8.3%
1/12 • From Day 0 to follow up (Day 28+14)
|
|
Nervous system disorders
Headache
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
8.3%
1/12 • From Day 0 to follow up (Day 28+14)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.9%
3/38 • From Day 0 to follow up (Day 28+14)
|
8.3%
1/12 • From Day 0 to follow up (Day 28+14)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
8.3%
1/12 • From Day 0 to follow up (Day 28+14)
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.6%
1/38 • From Day 0 to follow up (Day 28+14)
|
0.00%
0/12 • From Day 0 to follow up (Day 28+14)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/38 • From Day 0 to follow up (Day 28+14)
|
8.3%
1/12 • From Day 0 to follow up (Day 28+14)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submit-ted for publication or presentation. 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