Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the safety and efficacy will be evaluated for up to 60 weeks treatment as required of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face and intertriginous areas (= open-label phase).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 80190 | Experimental | Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190) |
|
| LEO 80190 vehicle | Placebo Comparator | Ointment Vehicle |
|
| Calcipotriol | Active Comparator | Calcipotriol 25 mcg/g in the ointment vehicle |
|
| Hydrocortisone | Active Comparator | Hydrocortisone 10 mg/g in the ointment vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriol plus hydrocortisone (LEO 80190) | Drug | Once daily application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase | 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, Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline (Visit 1) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline (Visit 1) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face. | At Week 8 (end of treatment for double-blind phase) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase | The assessment of the disease severity of the face was made using the 6-category scale below. Clear Almost clear Mild Moderate Severe Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Bieber, MD | Department of Dermatology and Allergy, University of Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Croatia - managed by CRO | Zagreb | 10000 | Croatia | |||
| Macedonia - managed by CRO |
Not provided
Not provided
Not provided
Not provided
Not provided
The Randomized double-blind phase of the study lasted up to 8 weeks, and was followed by a 52-week Open-label period in which participants had the opportunity to receive Calcipotriol 25 mcg/g plus 10 mg/g Hydrocortisone ointment.
A total of 1245 subjects were enrolled (informed consent signed and CRF started). Five subjects left the study during washout (2 screening failures, 2 lost to follow-up and 1 unacceptable adverse event). One subject attended Visit 1 but was not randomized (voluntary withdrawal). Therefore, 1239 of the enrolled subjects were randomized in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LEO 80190 | Once daily application Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190) |
| FG001 | Calcipotriol | Once daily application Calcipotriol 25 mcg/g in the ointment vehicle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 8-week, Double-blind, 4-arm |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LEO 80190 Vehicle |
| Drug |
|
| Hydrocortisone | Drug |
|
| Calcipotriol | Drug |
|
| At Week 4 |
| Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase | "Success" was defined as a TSS score of 0 or 1. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none (no erythema) 1 = mild (faint erythema, pink to very light red) 2 = moderate (definite light red erythema) 3 = severe (dark red erythema) 4 = very severe (very dark red erythema) Thickness 0 = none (no plaque elevation) 1 = mild (slight, barely perceptible elevation) 2 = moderate (definite elevation but not thick) 3 = severe (definite elevation, thick plaque with sharp edge) 4 = very severe (very thick plaque with sharp edge) Scaliness 0 = none (no scaling) 1 = mild (sparse, fine-scale lesions, only partially covered) 2 = moderate (coarser scales, most of lesions covered) 3 = severe (entire lesion covered with coarse scales) 4 = very severe (very thick coarse scales, possibly fissured) The sum of the three scores constituted a TSS ranging from 0 to 12 | At Week 8 (end of treatment for double-blind phase) |
| Participants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase | The (sub)investigator made an assessment of the disease severity of the intertriginous areas using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the intertrigi-nous areas at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of disease severity of the intertriginous areas. For subjects with a baseline severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of disease severity of the intertriginous areas. | At Week 8 (end of treatment for double-blind phase) |
| Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase | The severity of the subject's psoriasis vulgaris on the intertriginous areas was evaluated in terms of the three clinical signs: redness, thickness and scaliness. All the defined intertriginous areas were rated separately using the same scale as for the investigator's assessment of clinical signs (redness, thickness and scaliness) of the face. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none
Thickness 0 = none
Scaliness 0 = none
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. "Success" was defined as a TSS score of 0 or 1. | At Week 8 (end of treatment for double-blind phase) |
| Zagreb |
| 10000 |
| Croatia |
| Slovenia - managed by CRO | Zagreb | 10000 | Croatia |
| Department of Dermatology and Allergy, University of Bonn | Bonn | 53105 | Germany |
| Czech Republic - managed by CRO | Warsaw | 02-019 | Poland |
| Hungary - managed by CRO | Warsaw | 02-019 | Poland |
| Latvia - managed by CRO | Warsaw | 02-019 | Poland |
| Poland - managed by CRO | Warsaw | 02-019 | Poland |
| Belgium - managed by CRO | Warsaw | Poland |
| The Netherlands - managed by CRO | Warsaw | Poland |
| Serbia - managed by CRO | New Belgrade | 11070 | Serbia |
| FG002 | Hydrocortisone | Once daily application Hydrocortisone 10 mg/g in the ointment vehicle |
| FG003 | LEO 80190 Vehicle | Once daily application Ointment Vehicle |
| FG004 | Open-label Phase | LEO 80190 ointment : calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment |
| COMPLETED |
|
| NOT COMPLETED |
|
| 52-week, Open-label, Single Arm |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LEO 80190 | Once daily application Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190) |
| BG001 | Calcipotriol | Once daily application Calcipotriol 25 mcg/g in the ointment vehicle |
| BG002 | Hydrocortisone | Once daily application Hydrocortisone 10 mg/g in the ointment vehicle |
| BG003 | LEO 80190 Vehicle | Once daily application Ointment Vehicle |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase | 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, Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline (Visit 1) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline (Visit 1) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face. | Posted | Count of Participants | Participants | At Week 8 (end of treatment for double-blind phase) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase | The assessment of the disease severity of the face was made using the 6-category scale below. Clear Almost clear Mild Moderate Severe Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face. | Posted | Count of Participants | Participants | At Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase | "Success" was defined as a TSS score of 0 or 1. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none (no erythema) 1 = mild (faint erythema, pink to very light red) 2 = moderate (definite light red erythema) 3 = severe (dark red erythema) 4 = very severe (very dark red erythema) Thickness 0 = none (no plaque elevation) 1 = mild (slight, barely perceptible elevation) 2 = moderate (definite elevation but not thick) 3 = severe (definite elevation, thick plaque with sharp edge) 4 = very severe (very thick plaque with sharp edge) Scaliness 0 = none (no scaling) 1 = mild (sparse, fine-scale lesions, only partially covered) 2 = moderate (coarser scales, most of lesions covered) 3 = severe (entire lesion covered with coarse scales) 4 = very severe (very thick coarse scales, possibly fissured) The sum of the three scores constituted a TSS ranging from 0 to 12 | Posted | Count of Participants | Participants | At Week 8 (end of treatment for double-blind phase) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase | The (sub)investigator made an assessment of the disease severity of the intertriginous areas using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the intertrigi-nous areas at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of disease severity of the intertriginous areas. For subjects with a baseline severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of disease severity of the intertriginous areas. | Posted | Count of Participants | Participants | At Week 8 (end of treatment for double-blind phase) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase | The severity of the subject's psoriasis vulgaris on the intertriginous areas was evaluated in terms of the three clinical signs: redness, thickness and scaliness. All the defined intertriginous areas were rated separately using the same scale as for the investigator's assessment of clinical signs (redness, thickness and scaliness) of the face. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none
Thickness 0 = none
Scaliness 0 = none
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. "Success" was defined as a TSS score of 0 or 1. | Posted | Count of Participants | Participants | At Week 8 (end of treatment for double-blind phase) |
|
Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2)
The adverse events where collected for the the safety analysis set (SAS). The SAS consisted of those randomized patients who received any treatment with trial medication and for whom the presence or confirmed absence of adverse events were available. In total, 1235 subjects are included in the safety analysis set.
Not provided
| 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 | Once daily application Calcipotriol plus hydrocortisone (LEO 80190) | 0 | 351 | 5 | 351 | 91 | 351 |
| EG001 | Calcipotriol | Once daily application Calcipotriol 25 mcg/g in the ointment vehicle | 0 | 341 | 5 | 341 | 100 | 341 |
| EG002 | Hydrocortisone | Once daily application Hydrocortisone 10 mg/g in the ointment vehicle | 0 | 362 | 4 | 362 | 70 | 362 |
| EG003 | LEO 80190 Vehicle | Once daily application Ointment Vehicle | 0 | 181 | 0 | 181 | 47 | 181 |
| EG004 | Open-label Phase | LEO 80190 ointment : calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment | 0 | 453 | 24 | 453 | 266 | 453 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Deafness traumatic | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Benign bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
| |
| Laryngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Diverticulitis | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Cervical vertebra injury | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (6.1) | Non-systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | Non-systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA (6.1) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (6.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Cystitis acute | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (6.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (6.1) | Non-systematic Assessment |
|
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 submit-ted 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 |
|---|---|
| C055085 | calcipotriene |
| 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 |
Not provided
Not provided
| Male |
|
| Croatia |
|
| Czechia |
|
| Germany |
|
| Hungary |
|
| Latvia |
|
| Macedonia |
|
| Netherlands |
|
| Poland |
|
| Serbia |
|
| Slovenia |
|
| Cochran-Mantel-Haenszel |
| <0.001 |
| Odds Ratio (OR) |
| 1.79 |
| 2-Sided |
| 95 |
| 1.31 |
| 2.45 |
| Superiority |
| Test for superiority of LEO 80190 ointment versus ointment vehicle at Week 8 LOCF (Last Observation Carried Forward). | Cochran-Mantel-Haenszel | <0.001 | Odds Ratio (OR) | 2.70 | 2-Sided | 95 | 1.80 | 4.04 | Superiority |
| LEO 80190 Vehicle |
Once daily application Ointment Vehicle |
|
|
| Hydrocortisone |
Once daily application Hydrocortisone 10 mg/g in the ointment vehicle |
| OG003 | LEO 80190 Vehicle | Once daily application Ointment Vehicle |
|
|
| OG003 | LEO 80190 Vehicle | Once daily application Ointment Vehicle |
|
|
| OG002 |
| Hydrocortisone |
Once daily application Hydrocortisone 10 mg/g in the ointment vehicle |
| OG003 | LEO 80190 Vehicle | Once daily application Ointment Vehicle |
|
|