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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 80190 ointment | Active Comparator |
| |
| Hydrocortisone 10 mg/g ointment | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 80190 | Drug | Applied once daily |
| |
| Hydrocortisone |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (Day 0) to end of treatment (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Cambazard, MD | FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne Hôpital NOrd | Saint-Etienne | 42055 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 80190 Ointment | LEO 80190: Applied once daily |
| FG001 | Hydrocortisone 10 mg/g Ointment | Hydrocortisone: Applied once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
Applied once daily |
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| At end of treatment (Week 8) |
| 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. | From baseline (Day 0) to Week 4 (Day 28) |
| 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. | At end of treatment (Week 8) |
| 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
Thickness 0.none
Scaliness 0.none
| From baseline (Day 0) to end of treatment (Week 8) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 80190 Ointment | LEO 80190: Applied once daily |
| BG001 | Hydrocortisone 10 mg/g Ointment | Hydrocortisone: Applied once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of change in PASI | From baseline (Day 0) to end of treatment (Week 8) |
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| 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. | Posted | Count of Participants | Participants | At end of treatment (Week 8) |
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| 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. | Posted | Mean | Standard Deviation | percentage of change in PASI | From baseline (Day 0) to Week 4 (Day 28) |
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| 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. | 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. | Posted | Count of Participants | Participants | At end of treatment (Week 8) |
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| 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
Thickness 0.none
Scaliness 0.none
| 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. | Posted | Mean | Standard Deviation | percentage in TSS | From baseline (Day 0) to end of treatment (Week 8) |
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From baseline (Day 0) to follow-up
Follow-up visit only applicable if an AE (serious or non-serious) classified as possibly / probably related to the study medication or not assessable in relation to the study medication was present at the subject's last on-treatment visit. This follow-up had to be performed 14 ± 2 days after the subject's last on-treatment visit or until final outcome of the AE was determined, whichever came first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LEO 80190 Ointment | LEO 80190: Applied once daily | 0 | 27 | 0 | 27 | 17 | 27 |
| EG001 | Hydrocortisone 10 mg/g Ointment | Hydrocortisone: Applied once daily | 0 | 13 | 0 | 13 | 9 | 13 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Application site burning | General disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Bladder infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Pruritus genital | Reproductive system and breast disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Rash scaly | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
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The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 4494 5888 | disclosure@leo-pharma.com |
| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
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| 12-14 |
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| 15-17 |
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| Male |
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| France |
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| Germany |
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