Psoriasis Vulgaris
Conditions
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
Interventions
DRUGLEO 80190
Applied once daily
DRUGHydrocortisone
Applied once daily
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment | From baseline (Day 0) to end of treatment (Week 8) | 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
| Measure | Time frame | Description |
|---|---|---|
| Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF | At end of treatment (Week 8) | 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 | From baseline (Day 0) to Week 4 (Day 28) | 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 end of treatment (Week 8) | 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 | From baseline (Day 0) to end of treatment (Week 8) | 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 1. mild 2. moderate 3. severe 4. very severe Thickness 0.none 1. mild 2. moderate 3. severe 4. very severe Scaliness 0.none 1. mild 2. moderate 3. severe 4. 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LEO 80190 Ointment LEO 80190: Applied once daily | 27 |
| Hydrocortisone 10 mg/g Ointment Hydrocortisone: Applied once daily | 13 |
| Total | 40 |
Baseline characteristics
| Characteristic | LEO 80190 Ointment | Total | Hydrocortisone 10 mg/g Ointment |
|---|---|---|---|
| Age, Customized Years 12-14 | 5 Participants | 7 Participants | 2 Participants |
| Age, Customized Years 15-17 | 8 Participants | 12 Participants | 4 Participants |
| Age, Customized Years 6-8 | 6 Participants | 9 Participants | 3 Participants |
| Age, Customized Years 9-11 | 8 Participants | 12 Participants | 4 Participants |
| Region of Enrollment Canada | 6 Participants | 8 Participants | 2 Participants |
| Region of Enrollment France | 10 Participants | 16 Participants | 6 Participants |
| Region of Enrollment Germany | 11 Participants | 16 Participants | 5 Participants |
| Sex: Female, Male Female | 19 Participants | 26 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 13 |
| other Total, other adverse events | 17 / 27 | 9 / 13 |
| serious Total, serious adverse events | 0 / 27 | 0 / 13 |
Outcome results
Primary
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.
Time frame: From baseline (Day 0) to end of treatment (Week 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80190 Ointment | The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment | -60.8 percentage of change in PASI | Standard Deviation 51.1 |
| Hydrocortisone 10 mg/g Ointment | The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment | -54.2 percentage of change in PASI | Standard Deviation 59.2 |
p-value: 0.7595% CI: [-43.7, 31.7]ANOVA
Secondary
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.
Time frame: At end of treatment (Week 8)
Population: The intertriginous analysis set consisted of all participants having 'Mild' or worse according to IGA of the intertriginous areas at baseline. The intertriginous analysis set therefore consisted of 11 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 80190 Ointment | Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF | Controlled | 2 Participants |
| LEO 80190 Ointment | Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF | Non-controlled | 5 Participants |
| Hydrocortisone 10 mg/g Ointment | Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF | Controlled | 4 Participants |
| Hydrocortisone 10 mg/g Ointment | Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF | Non-controlled | 0 Participants |
Secondary
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.
Time frame: At end of treatment (Week 8)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LEO 80190 Ointment | Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF | Controlled | 13 Participants |
| LEO 80190 Ointment | Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF | Non-controlled | 14 Participants |
| Hydrocortisone 10 mg/g Ointment | Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF | Controlled | 7 Participants |
| Hydrocortisone 10 mg/g Ointment | Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF | Non-controlled | 6 Participants |
Secondary
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.
Time frame: From baseline (Day 0) to Week 4 (Day 28)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80190 Ointment | The Percentage Change in PASI of the Face LOCF at Week 4 | -54.8 percentage of change in PASI | Standard Deviation 33.8 |
| Hydrocortisone 10 mg/g Ointment | The Percentage Change in PASI of the Face LOCF at Week 4 | -54.9 percentage of change in PASI | Standard Deviation 37.3 |
Secondary
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 1. mild 2. moderate 3. severe 4. very severe Thickness 0.none 1. mild 2. moderate 3. severe 4. very severe Scaliness 0.none 1. mild 2. moderate 3. severe 4. 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)
Population: The intertriginous analysis set consisted of all participants having 'Mild' or worse according to IGA of the intertriginous areas at baseline. The intertriginous analysis set therefore consisted of 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LEO 80190 Ointment | The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF | -56.6 percentage in TSS | Standard Deviation 38.2 |
| Hydrocortisone 10 mg/g Ointment | The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF | -93.2 percentage in TSS | Standard Deviation 8.2 |