| Primary | Percentage of Subjects With Adverse Drug Reactions (ADRs) | Adverse events for which the investigator did not describe the causal relationship to IP as not related | | Posted | | Number | | percent subjects | | Throughout trial, up to 8-weeks | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | | Title | Denominators | Categories |
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| Primary | Change in Albumincorrected Serum Calcium From Baseline to Week 4 | Change in albumincorrected serum calcium from Baseline to week 4 | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Primary | Change in Albumincorrected Serum Calcium From Baseline to Week 8 | Change in albumincorrected serum calcium from Baseline to week 8 | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Secondary | Change in Plasma PTH From Baseline to Week 4 | Change in plasma PTH (parathyroid hormone) from Baseline to week 4 | | Posted | | Mean | Standard Deviation | ng/L | | Baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Secondary | Change in Plasma PTH From Baseline to Week 8 | Change in plasma PTH (parathyroid hormone) from Baseline to week 8 | | Posted | | Mean | Standard Deviation | ng/L | | Baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Secondary | Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2 | Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 2. The IGA Scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe. | | Posted | | Number | | participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4 | Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 4 | | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8 | Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at week 8 | | Posted | | Number | | participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Primary | Change in Albumincorrected Serum Calcium From Baseline to End of Treatment | Change in albumincorrected serum calcium from Baseline to end of treatment | | Posted | | Mean | Standard Error | mmol/L | | Baseline and End of treatment (up to 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Primary | Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4 | Change in 24-hour urinary calcium excretion from Baseline to week 4 | | Posted | | Mean | Standard Deviation | mmol/24hr | | Baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Primary | Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8 | Change in 24-hour urinary calcium excretion from Baseline to week 8 | | Posted | | Mean | Standard Deviation | mmol/24hr | | Baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Primary | Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment | Change in 24-hour urinary calcium excretion from Baseline to end of treatment | | Posted | | Mean | Standard Deviation | mmol/24hr | | Baseline and End of treatment (up to 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Primary | Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4 | Change in urinary calcium:creatinine ratio from Baseline to week 4 | | Posted | | Mean | Standard Deviation | mmol/g | | Baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Primary | Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8 | Change in urinary calcium:creatinine ratio from Baseline to week 8 | | Posted | | Mean | Standard Deviation | mmol/g | | Baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Primary | Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment | Change in urinary calcium:creatinine ratio from Baseline to end of treatment | | Posted | | Mean | Standard Deviation | mmol/g | | Baseline and End of treatment (up to 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |
| Secondary | Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at End of Treatment | Disease severity of the scalp psoriasis as assessed by the 6-point scale IGA, based on the condition of the disease at the time of evaluation at end of treatment | | Posted | | Number | | participants | | End of treatment (up to 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness)From Baseline to Week 2 | Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome). | | Posted | | Mean | Standard Deviation | percentage of change | | Baseline and week 2 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 4 | Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 to 12 points. | | Posted | | Mean | Standard Deviation | percent of change | | Baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Week 8 | Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome). | | Posted | | Mean | Standard Deviation | percent change | | Baseline and week 8 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to End of Treatment. | Investigator assessment of scalp psoriasis lesions in terms of the three clinical signs: redness, thickness, and scaliness. Each clinical sign, a single score (ranging from 0 to 4), reflecting the average severity of all psoriatic lesions on the scalp, were determined. The sum of the three scores (redness, thickness, and scaliness) constitutes the Total Sign Score of the psoriasis on scalp, ranging from 0 (best possible outcome) to 12 points (worst possible outcome). | | Posted | | Mean | Standard Deviation | percent of change | | Baseline and End of treatment (up to 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2 | Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. The scale: 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe. | | Posted | | Number | | participants | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4 | Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. | | Posted | | Number | | participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8 | Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. | | Posted | | Number | | participants | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment | Disease severity of the scalp psoriasis as assessed by the 5-point scale, Patient's Global Assessment of Disease Severity, based on the condition of the disease at the time of evaluation. | | Posted | | Number | | participants | | End of treatment (up to 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| |
| Secondary | Withdrawal | How many subjects withdrew from the study. Reasons for withdrawal: due to exclusion criteria emerging, due to AE(s), or due to other reason | | Posted | | Number | | participants | | Week 4 and 8 | | | | ID | Title | Description |
|---|
| OG000 | LEO 80185 Gel Once Daily Application | Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp. |
| | |