Back to resultsA Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
LEO 80190
Hydrocortisone
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of psoriasis vulgaris involving the face
- Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severity of psoriasis vulgaris on trunk and/or limbs should be amenable to topical therapy with any of the allowed medications
- An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of all facial lesions)
- Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) of ointment per week
- Disease severity graded as mild, moderate or severe according to the investigator's global assessment of disease severity of the face
- Aged 6 to 17 years
Exclusion Criteria:
- Systemic treatment with therapies other than biologicals with a potential effect on psoriasis vulgaris within the 4-week period prior to randomisation
- Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
- PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
- UVB therapy within the 2-week period prior to randomisation
- Topical treatment of psoriasis vulgaris lesions on the face or on the intertriginous areas within the 2-week period prior to randomisation
- Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
- Initiation of or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the treatment phase of the study
- Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
Sites / Locations
- CHU Saint-Etienne Hôpital NOrd
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
LEO 80190 ointment
Hydrocortisone 10 mg/g ointment
Arm Description
Outcomes
Primary Outcome Measures
The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment
PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula:
0.05 (R+T+S) E
It ranged from 0 to 3.6.
Secondary Outcome Measures
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF
For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of the face.
For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of the face.
At baseline (Day 0) to end of treatment (Week 8) the (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below.
Clear, almost clear, mild, moderate, severe and very severe.
The Percentage Change in PASI of the Face LOCF at Week 4
PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula:
0.05 (R+T+S) E It ranged from 0 to 3.6.
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF
At baseline (Day 0) to end of treatment (Week 8) the (sub)investigator made an assessment of the disease severity of the intertriginous areas using the following 6-category scale.
Clear, almost clear, mild, moderate, severe and very severe.
For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of the intertriginous areas.
For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of the intertriginous areas.
The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF
For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the intertriginous areas was determined according to the scale below:
Redness 0.none
mild
moderate
severe
very severe
Thickness
0.none
mild
moderate
severe
very severe
Scaliness
0.none
mild
moderate
severe
very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS ranging from 0 to 12.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01007591
Brief Title
A Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas
Official Title
Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) With Psoriasis Vulgaris on the Face and on the Intertriginous Areas
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An international, multi-centre, prospective, randomised, double-blind, active-controlled, 2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17 years) with psoriasis vulgaris on the face and on the intertriginous areas
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 80190 ointment
Arm Type
Active Comparator
Arm Title
Hydrocortisone 10 mg/g ointment
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
LEO 80190
Intervention Description
Applied once daily
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
Applied once daily
Primary Outcome Measure Information:
Title
The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment
Description
PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula:
0.05 (R+T+S) E
It ranged from 0 to 3.6.
Time Frame
From baseline (Day 0) to end of treatment (Week 8)
Secondary Outcome Measure Information:
Title
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF
Description
For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of the face.
For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of the face.
At baseline (Day 0) to end of treatment (Week 8) the (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below.
Clear, almost clear, mild, moderate, severe and very severe.
Time Frame
At end of treatment (Week 8)
Title
The Percentage Change in PASI of the Face LOCF at Week 4
Description
PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula:
0.05 (R+T+S) E It ranged from 0 to 3.6.
Time Frame
From baseline (Day 0) to Week 4 (Day 28)
Title
Participants With "Controlled Disease" According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF
Description
At baseline (Day 0) to end of treatment (Week 8) the (sub)investigator made an assessment of the disease severity of the intertriginous areas using the following 6-category scale.
Clear, almost clear, mild, moderate, severe and very severe.
For subjects with a baseline (Day 0) severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of the intertriginous areas.
For subjects with a baseline (Day 0) severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of the intertriginous areas.
Time Frame
At end of treatment (Week 8)
Title
The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF
Description
For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the intertriginous areas was determined according to the scale below:
Redness 0.none
mild
moderate
severe
very severe
Thickness
0.none
mild
moderate
severe
very severe
Scaliness
0.none
mild
moderate
severe
very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS ranging from 0 to 12.
Time Frame
From baseline (Day 0) to end of treatment (Week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of psoriasis vulgaris involving the face
Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severity of psoriasis vulgaris on trunk and/or limbs should be amenable to topical therapy with any of the allowed medications
An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of all facial lesions)
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) of ointment per week
Disease severity graded as mild, moderate or severe according to the investigator's global assessment of disease severity of the face
Aged 6 to 17 years
Exclusion Criteria:
Systemic treatment with therapies other than biologicals with a potential effect on psoriasis vulgaris within the 4-week period prior to randomisation
Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
UVB therapy within the 2-week period prior to randomisation
Topical treatment of psoriasis vulgaris lesions on the face or on the intertriginous areas within the 2-week period prior to randomisation
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
Initiation of or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the treatment phase of the study
Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Cambazard, MD
Organizational Affiliation
FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne Hôpital NOrd
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas
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