Trial Outcomes & Findings for The Pharmacokinetics of LEO 90105 (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Extensive Psoriasis Vulgaris (NCT NCT01768013)
NCT ID: NCT01768013
Last Updated: 2025-03-12
Results Overview
The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.
COMPLETED
PHASE1/PHASE2
13 participants
Day 1
2025-03-12
Participant Flow
First subject first visit: 09-Jul-2012 Last subject last visit: 30-Oct-2012
Prior to treatment at Visit 1, a washout period was completed if the subject was treated or had recently been treated with anti-psoriatic treatments or other relevant medication, as defined by the exclusion criteria. The washout period could last up to a maximum of 4 weeks.
Participant milestones
| Measure |
LEO 90105 Ointment
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Overall Study
STARTED
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13
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Pharmacokinetics of LEO 90105 (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Japanese Subjects With Extensive Psoriasis Vulgaris
Baseline characteristics by cohort
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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8 Participants
n=5 Participants
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Age, Categorical
>=65 years
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5 Participants
n=5 Participants
|
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Age, Continuous
|
54.2 years
STANDARD_DEVIATION 15.4 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
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13 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: Cmax of Betamethasone Dipropionate
|
NA pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 7The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: Cmax of Betamethasone Dipropionate
|
NA pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 14The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: Cmax of Betamethasone Dipropionate
|
NA pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 1The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of Betamethasone Dipropionate
|
NA h*pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 7The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
|
Pharmacokinetic: AUClast of Betamethasone Dipropionate
|
NA h*pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 14The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of Betamethasone Dipropionate
|
NA h*pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 1The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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Pharmacokinetic: Cmax of Betamethasone 17-propionate
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218.8 pg/mL
Standard Deviation 351.01
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PRIMARY outcome
Timeframe: Day 7The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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Pharmacokinetic: Cmax of Betamethasone 17-propionate
|
101.5 pg/mL
Standard Deviation 77.551
|
PRIMARY outcome
Timeframe: Day 14The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: Cmax of Betamethasone 17-propionate
|
116 pg/mL
Standard Deviation 64.826
|
PRIMARY outcome
Timeframe: Day 1The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of Betamethasone 17-propionate
|
1036.7 h*pg/mL
Standard Deviation 1885.01
|
PRIMARY outcome
Timeframe: Day 7The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of Betamethasone 17-propionate
|
570.92 h*pg/mL
Standard Deviation 517.107
|
PRIMARY outcome
Timeframe: Day 14The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of Betamethasone 17-propionate
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634.65 h*pg/mL
Standard Deviation 467.426
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PRIMARY outcome
Timeframe: Day 1The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: Cmax of Calcipotriol
|
107.6 pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 7The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: Cmax of Calcipotriol
|
NA pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 14The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: Cmax of Calcipotriol
|
NA pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 1The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of Calcipotriol
|
169.6 h*pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 7The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of Calcipotriol
|
NA h*pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 14The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of Calcipotriol
|
NA h*pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 1The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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Pharmacokinetic: Cmax of MC1080
|
95.35 pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 7The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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Pharmacokinetic: Cmax of MC1080
|
57.57 pg/mL
Standard Deviation 36.218
|
PRIMARY outcome
Timeframe: Day 14The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: Cmax of MC1080
|
NA pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 1The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of MC1080
|
430.9 h*pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
PRIMARY outcome
Timeframe: Day 7To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Pharmacokinetic: AUClast of MC1080.
|
221.2 h*pg/mL
Standard Deviation 175.16
|
PRIMARY outcome
Timeframe: Day 14The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
|
Pharmacokinetic: AUClast of MC1080.
|
NA h*pg/mL
Standard Deviation NA
The pharmacokinetic parameter could not be reliably estimated
|
SECONDARY outcome
Timeframe: Baseline to Day 28Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease. The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified.
Outcome measures
| Measure |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Efficacy: Percentage Change in m-PASI From Baseline to Day 28
|
-72.4 percentage of change
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: Day 28Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28. Investigator global assessment (IGA) is based on the investigator's assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is 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 |
LEO 90105 Ointment
n=13 Participants
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.
|
6 participants
|
Adverse Events
LEO 90105 Ointment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LEO 90105 Ointment
n=13 participants at risk
Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
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|---|---|
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Gastrointestinal disorders
Abdominal discomfort
|
7.7%
1/13
|
|
Infections and infestations
Folliculitis
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
Skin injury
|
7.7%
1/13
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13
|
|
Vascular disorders
Orthostatic hypotension
|
7.7%
1/13
|
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