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Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02387853
Recruitment Status : Completed
First Posted : March 13, 2015
Results First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Intervention Drug: LEO 90100
Enrollment 117
Recruitment Details  
Pre-assignment Details 117 subjects were enrolled, this number includes all subjects who provided consent for participation in the trial and were screened. Out of the 117 subjects who were screened, 106 subjects met all inclusion criteria and none of the exclusion criteria, and were started on treatment in the LEO 90100 arm.
Arm/Group Title LEO 90100
Hide Arm/Group Description LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Period Title: Overall Study
Started 106
Completed 103
Not Completed 3
Arm/Group Title LEO 90100
Hide Arm/Group Description LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional baseline and post-baseline HPA axis assessments and constitute the per protocol analysis set.
Overall Number of Baseline Participants 106
Hide Baseline Analysis Population Description
Of the 117 subjects who were enrolled in the trial and screened, 106 subjects met all inclusion criteria and none of the exclusion criteria. These 106 subjects comprise the Baseline Analysis Population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants
14.2  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Female
61
  57.5%
Male
45
  42.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Hispanic or Latino
3
   2.8%
Not Hispanic or Latino
103
  97.2%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
White
102
  96.2%
Native Hawaiian or Other Pacific Islander
1
   0.9%
Other
3
   2.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Netherlands
9
   8.5%
Romania
32
  30.2%
United States
2
   1.9%
Poland
63
  59.4%
Fitzpatrick Skin Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Type I
5
   4.7%
Type II
44
  41.5%
Type III
46
  43.4%
Type IV
10
   9.4%
Type V
1
   0.9%
[1]
Measure Description:

Fitzpatrick skin type is based on skin reaction to first 30-45 minutes sun exposure after a winter with no sun exposure:

Type I: Unexposed skin color: white, always burns easily, never tans. Type II: Unexposed skin color: white, always burns easily, tans minimally. Type III: Unexposed skin color: white, burns moderately, tans gradually (light brown).

Type IV: Unexposed skin color: white, burns minimally, always tans well (moderate brown).

Type V: Unexposed skin color: brown, rarely burns, tans profusely (dark brown). Type VI: Unexposed skin color: black, never burns, deeply pigmented.

Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 106 participants
165.79  (9.77)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 106 participants
60.01  (14.41)
Duration of plaque psoriasis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants
4.3  (2.9)
1.Primary Outcome
Title Number of Subjects With Adverse Events (AEs)
Hide Description Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Time Frame From Week -1 to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 106
Measure Type: Count of Participants
Unit of Measure: Participants
Upper respiratory tract infection
8
   7.5%
Nasopharyngitis
4
   3.8%
Folliculitis
1
   0.9%
Impetigo
1
   0.9%
Oral herpes
1
   0.9%
Pharyngitis
1
   0.9%
Pulpitis dental
1
   0.9%
Rhinitis
1
   0.9%
Acne
2
   1.9%
Erythema
1
   0.9%
Pruritus generalised
1
   0.9%
Psoriasis
1
   0.9%
Skin reaction
1
   0.9%
Application site pain
1
   0.9%
Product physical consistency issue
1
   0.9%
Arthralgia
1
   0.9%
Myalgia
1
   0.9%
Myopia
1
   0.9%
Arthropod bite
1
   0.9%
Haemangioma of liver
1
   0.9%
Skin neoplasm excision
1
   0.9%
2.Primary Outcome
Title Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
Hide Description Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
Time Frame 30 minutes after ACTH-challenge at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis set
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
Serum cortisol equal to or below 18 mcg/dl
3
   9.1%
Serum cortisol above 18 mcg/dl
30
  90.9%
3.Primary Outcome
Title Change in Albumin-corrected Serum Calcium From Baseline to Week 4
Hide Description Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Time Frame From baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 101
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.016  (0.119)
4.Primary Outcome
Title Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
Hide Description Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Time Frame From baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
24-hour urine HPA set
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: mmol/24hr
-0.335  (2.076)
5.Primary Outcome
Title Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4
Hide Description Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.
Time Frame From baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
24-hour urine in HPA set
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mmol/g
-0.2892  (2.1185)
6.Secondary Outcome
Title Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4
Hide Description Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
Time Frame 30 and 60 minutes after ACTH-challenge at Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis set
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
Serum cortisol equal to or below 18 mcg/dL
1
   3.0%
Serum cortisol above 18 mcg/dl
32
  97.0%
7.Secondary Outcome
Title Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4
Hide Description Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing.
Time Frame From baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Spot urine non-HPA set
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 48
Mean (Standard Deviation)
Unit of Measure: mmol/g
0.4620  (1.8892)
8.Secondary Outcome
Title Number of Subjects With ‘Treatment Success’ According to Physician's Global Assessment (PGA) on Body
Hide Description Number of subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on Body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 103
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
74
  71.8%
No
29
  28.2%
9.Secondary Outcome
Title Number of Subjects With ‘Treatment Success’ According to Physician's Global Assessment (PGA) on Scalp
Hide Description Number of subjects with ‘treatment success’ according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 103
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
78
  75.7%
No
25
  24.3%
10.Secondary Outcome
Title Percentage Change in PASI From Baseline to Week 4
Hide Description Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.
Time Frame From baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: Percentage change in PASI
-82.05  (17.87)
11.Secondary Outcome
Title Number of Subjects With ‘Treatment Success’ According to the Subject’s Global Assessment of Disease Severity on the Body at Week 4
Hide Description Number of subjects with ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 103
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
86
  83.5%
No
17
  16.5%
12.Secondary Outcome
Title Number of Subjects With ‘Treatment Success’ According to the Subject’s Global Assessment of Disease Severity on the Scalp at Week 4
Hide Description Number of subjects with ‘treatment success’ according to the Subject’s Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 103
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
84
  81.6%
No
19
  18.4%
13.Secondary Outcome
Title Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4
Hide Description Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome.
Time Frame From baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Arm/Group Title LEO 90100
Hide Arm/Group Description:
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: mm on VAS scale
-32.5  (27.3)
Time Frame From Day -28 up to Day 56
Adverse Event Reporting Description During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
 
Arm/Group Title LEO 90100
Hide Arm/Group Description LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional HPA axis assessments and constitute the per protocol analysis set.
All-Cause Mortality
LEO 90100
Affected / at Risk (%)
Total   0/106 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
LEO 90100
Affected / at Risk (%) # Events
Total   0/106 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LEO 90100
Affected / at Risk (%) # Events
Total   22/106 (20.75%)    
Eye disorders   
Myopia * 1  1/106 (0.94%)  1
General disorders   
Application site pain * 1  1/106 (0.94%)  1
Product physical consistency issue * 1  1/106 (0.94%)  1
Infections and infestations   
Upper respiratory tract infection * 1  8/106 (7.55%)  8
Nasopharyngitis * 1  4/106 (3.77%)  4
Folliculitis * 1  1/106 (0.94%)  1
Impetigo * 1  1/106 (0.94%)  1
Oral herpes * 1  1/106 (0.94%)  1
Pharyngitis * 1  1/106 (0.94%)  1
Pulpitis dental * 1  1/106 (0.94%)  1
Rhinitis * 1  1/106 (0.94%)  1
Injury, poisoning and procedural complications   
Arthropod bite * 1  1/106 (0.94%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/106 (0.94%)  1
Myalgia * 1  1/106 (0.94%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Haemangioma of liver * 1  1/106 (0.94%)  1
Skin and subcutaneous tissue disorders   
Acne * 1  2/106 (1.89%)  2
Erythema * 1  1/106 (0.94%)  1
Pruritus generalised * 1  1/106 (0.94%)  1
Psoriasis * 1  1/106 (0.94%)  1
Skin reaction * 1  1/106 (0.94%)  1
Surgical and medical procedures   
Skin neoplasm excision * 1  1/106 (0.94%)  1
1
Term from vocabulary, MedDRA 18.0
*
Indicates events were collected by non-systematic assessment
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 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Disclosure Specialist
Organization: LEO Pharma A/S
Phone: +45 44945888
EMail: disclosure@leo-pharma.com
Layout table for additonal information
Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02387853     History of Changes
Other Study ID Numbers: LP0053-1108
First Submitted: March 12, 2015
First Posted: March 13, 2015
Results First Submitted: September 28, 2018
Results First Posted: January 15, 2019
Last Update Posted: January 15, 2019