Trial Outcomes & Findings for Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis (NCT NCT01120223)

Results Overview

Adverse events for which the investigator did not describe the causal relationship to IP as not related

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

Throughout trial, up to 8-weeks

Results posted on

2025-03-11

Participant Flow

Start date: 22-Nov-2010 Completion date: 15-Oct-2012

Prior to Visit 1 (Day 0), a wash-out period (up to 8 weeks, as defined by the exclusion criteria) was to be completed if the subject had been treated with antipsoriatic treatments or other relevant medication; 2 screening visits were planned.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	78
Overall Study COMPLETED	74
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of LEO 80185 Gel in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
Age, Categorical <=18 years	78 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	14.6 years STANDARD_DEVIATION 1.7 • n=99 Participants
Sex: Female, Male Female	43 Participants n=99 Participants
Sex: Female, Male Male	35 Participants n=99 Participants
Region of Enrollment France	22 participants n=99 Participants
Region of Enrollment Canada	37 participants n=99 Participants
Region of Enrollment United Kingdom	19 participants n=99 Participants

PRIMARY outcome

Timeframe: Throughout trial, up to 8-weeks

Adverse events for which the investigator did not describe the causal relationship to IP as not related

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
Percentage of Subjects With Adverse Drug Reactions (ADRs)	6.4 percent subjects

PRIMARY outcome

Timeframe: Baseline and week 4

Change in albumincorrected serum calcium from Baseline to week 4

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=77 Participants 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.
Change in Albumincorrected Serum Calcium From Baseline to Week 4	-0.014 mmol/L Standard Deviation 0.139

PRIMARY outcome

Timeframe: Baseline and week 8

Change in albumincorrected serum calcium from Baseline to week 8

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=60 Participants 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.
Change in Albumincorrected Serum Calcium From Baseline to Week 8	-0.002 mmol/L Standard Deviation 0.098

PRIMARY outcome

Timeframe: Baseline and End of treatment (up to 8 weeks)

Change in albumincorrected serum calcium from Baseline to end of treatment

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
Change in Albumincorrected Serum Calcium From Baseline to End of Treatment	0.000 mmol/L Standard Error 0.101

PRIMARY outcome

Timeframe: Baseline and week 4

Change in 24-hour urinary calcium excretion from Baseline to week 4

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=76 Participants 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.
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4	-0.01 mmol/24hr Standard Deviation 1.54

PRIMARY outcome

Timeframe: Baseline and week 8

Change in 24-hour urinary calcium excretion from Baseline to week 8

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=60 Participants 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.
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8	0.03 mmol/24hr Standard Deviation 1.42

PRIMARY outcome

Timeframe: Baseline and End of treatment (up to 8 weeks)

Change in 24-hour urinary calcium excretion from Baseline to end of treatment

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=77 Participants 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.
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment	-0.03 mmol/24hr Standard Deviation 1.43

PRIMARY outcome

Timeframe: Baseline and week 4

Change in urinary calcium:creatinine ratio from Baseline to week 4

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=76 Participants 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.
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4	-0.269 mmol/g Standard Deviation 1.684

PRIMARY outcome

Timeframe: Baseline and week 8

Change in urinary calcium:creatinine ratio from Baseline to week 8

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=60 Participants 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.
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8	-0.003 mmol/g Standard Deviation 1.500

PRIMARY outcome

Timeframe: Baseline and End of treatment (up to 8 weeks)

Change in urinary calcium:creatinine ratio from Baseline to end of treatment

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=77 Participants 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.
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment	-0.1156 mmol/g Standard Deviation 1.679

SECONDARY outcome

Timeframe: Baseline and week 4

Change in plasma PTH (parathyroid hormone) from Baseline to week 4

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=74 Participants 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.
Change in Plasma PTH From Baseline to Week 4	1.2 ng/L Standard Deviation 16.0

SECONDARY outcome

Timeframe: Baseline and week 8

Change in plasma PTH (parathyroid hormone) from Baseline to week 8

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=61 Participants 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.
Change in Plasma PTH From Baseline to Week 8	-2.8 ng/L Standard Deviation 13.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 2	37 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4	59 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=61 Participants 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.
Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8	49 participants

SECONDARY outcome

Timeframe: End of treatment (up to 8 weeks)

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

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
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	66 participants

SECONDARY outcome

Timeframe: Baseline and 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).

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
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	-62.7 percentage of change Standard Deviation 22.3

SECONDARY outcome

Timeframe: Baseline and week 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.

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
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	-72.1 percent of change Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline and 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).

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=61 Participants 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.
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	-76.6 percent change Standard Deviation 23.5

SECONDARY outcome

Timeframe: Baseline and End of treatment (up to 8 weeks)

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).

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
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.	-80.4 percent of change Standard Deviation 22.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 2	44 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4	55 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=61 Participants 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.
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 8	51 participants

SECONDARY outcome

Timeframe: End of treatment (up to 8 weeks)

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.

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at End of Treatment	68 participants

SECONDARY outcome

Timeframe: Week 4 and 8

How many subjects withdrew from the study. Reasons for withdrawal: due to exclusion criteria emerging, due to AE(s), or due to other reason

Outcome measures

Outcome measures
Measure	LEO 80185 Gel Once Daily Application n=78 Participants 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.
Withdrawal	4 participants

Adverse Events

LEO 80185 Gel Once Daily Application

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LEO 80185 Gel Once Daily Application n=78 participants at risk 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.
Nervous system disorders Headache	5.1% 4/78
Infections and infestations Pharyngitis	5.1% 4/78
Infections and infestations Upper respiratory tract infection	5.1% 4/78

Additional Information

Clinical Trial Disclosure Manager

LEO Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO acknowledges the investigators' right to publish the results of the trial, irrespective of outcome. Pubs/presentations by investigator(s) shall not be made before the results of a joint publication is public. LEO retains the right to have any publication submitted to LEO for review at least 30 days prior to this paper being submitted for publication/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