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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01083758
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Scalp Psoriasis
Intervention Drug: LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)
Enrollment 31
Recruitment Details Start date: 12 April 2010 Completion date: 8 August 2012
Pre-assignment Details 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.
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description 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
Period Title: Overall Study
Started 31
Completed 29
Not Completed 2
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description 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 Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
31
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
14.8  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
19
  61.3%
Male
12
  38.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Percentage of Subjects With Adverse Drug Reactions (ADRs)
Hide Description Adverse events for which the investigator did not describe the causal relationship to IP as not related
Time Frame Throughout trial, up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
3.2
2.Primary Outcome
Title Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
Hide Description Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population (based on the Full Analysis Set, but excluding subjects who did not apply any study medication, meet the inclusion criterion concerning adrenal function at baseline, or provide any results for the ACTH-challenge test after receiving study treatment)
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
1
3.Primary Outcome
Title Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8
Hide Description Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.
Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
0
4.Primary Outcome
Title Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.
Hide Description Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
0
5.Primary Outcome
Title Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.
Hide Description Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.
Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
0
6.Primary Outcome
Title Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
Hide Description Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.
Time Frame Baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.028  (0.087)
7.Primary Outcome
Title Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
Hide Description Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: mmol/L
0.002  (0.087)
8.Primary Outcome
Title Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
Hide Description Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.
Time Frame Baseline and end of treatment (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.007  (0.090)
9.Primary Outcome
Title Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
Hide Description Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.
Time Frame Baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: mmol/24h
0.20  (2.26)
10.Primary Outcome
Title Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
Hide Description Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: mmol/24h
0.06  (2.35)
11.Primary Outcome
Title Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
Hide Description Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.
Time Frame Baseline and end of treatment (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: mmol/24h
0.12  (2.14)
12.Primary Outcome
Title Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.
Hide Description Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.
Time Frame Baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: mmol/g
-0.179  (1.848)
13.Primary Outcome
Title Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.
Hide Description Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: mmol/g
-0.005  (2.379)
14.Primary Outcome
Title Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.
Hide Description Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.
Time Frame Baseline and end of treatment (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: mmol/g
0.096  (2.142)
15.Secondary Outcome
Title Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8
Hide Description Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8
Time Frame Baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: ng/L
-3.2  (15.6)
16.Secondary Outcome
Title Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8
Hide Description Change in plasma PTH (parathyroid hormone) from Baseline (SV2 = screening visit 2) to Week 4 and Week 8
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: ng/L
-2.4  (15.2)
17.Secondary Outcome
Title Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
Hide Description 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. The IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate, 5 = severe, and 6 = very severe.
Time Frame week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
32.3
18.Secondary Outcome
Title Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
Hide Description 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.
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of participants
43.3
19.Secondary Outcome
Title Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
Hide Description 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.
Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: percentage of participants
53.8
20.Secondary Outcome
Title Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
Hide Description 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.
Time Frame End of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
54.8
21.Secondary Outcome
Title Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.
Hide Description 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).
Time Frame week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: Percentage change
-48.0  (31.0)
22.Secondary Outcome
Title Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.
Hide Description 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).
Time Frame Baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: percentage change
-48.8  (29.9)
23.Secondary Outcome
Title Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.
Hide Description 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).
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: Percentage change
-57.2  (33.9)
24.Secondary Outcome
Title Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.
Hide Description 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).
Time Frame Baseline and end of treatment (up to 8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: Percentage change
-59.2  (35.4)
25.Secondary Outcome
Title Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
Hide Description 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 scores are based on the following; 1 = clear, 2 = very mild, 3 = mild, 4 = moderate, 5 = severe.
Time Frame week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: % of participants w/ controlled disease
45.2
26.Secondary Outcome
Title Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
Hide Description 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.
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: % of participants w/ controlled disease
50.0
27.Secondary Outcome
Title Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
Hide Description 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.
Time Frame week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: % of participants w/ controlled disease
57.7
28.Secondary Outcome
Title Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
Hide Description 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.
Time Frame End of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description:
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 Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: % of participants w/ controlled disease
58.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LEO 80185 Gel
Hide Arm/Group Description 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
All-Cause Mortality
LEO 80185 Gel
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
LEO 80185 Gel
Affected / at Risk (%)
Total   0/31 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LEO 80185 Gel
Affected / at Risk (%)
Total   10/31 (32.26%) 
Infections and infestations   
Nasopharyngitis * 1  2/31 (6.45%) 
Upper respiratory tract * 1  2/31 (6.45%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/31 (9.68%) 
Oropharyngeal pain * 1  3/31 (9.68%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Clinical Trial Disclosure Manager
Organization: LEO Pharma A/S
Phone: +45 4494 5888
EMail: ctr.disclosure@leo-pharma.com
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01083758    
Other Study ID Numbers: MBL 0801
2008-007606-11 ( EudraCT Number )
First Submitted: March 8, 2010
First Posted: March 10, 2010
Results First Submitted: September 26, 2014
Results First Posted: October 12, 2015
Last Update Posted: October 12, 2015