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The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 90100 | Experimental | LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks |
|
| Aerosol foam vehicle | Placebo Comparator | Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks |
|
| Calcipotriol BDP gel | Active Comparator | Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks |
|
| Gel vehicle | Placebo Comparator | Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 90100 aerosol foam | Drug |
| ||
| Aerosol foam vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success According to the PGA | To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris. Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA). 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline. | 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel. | Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel. | Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel |
| Time to 'Treatment Success' According to PGA. |
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Inclusion Criteria:
Exclusion Criteria:
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants within 4 weeks prior to randomisation)
Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation
Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation
Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation
Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation
Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Dermatologie, Hôspital Larrey | Toulouse | 31059 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27531752 | Result | Paul C, Stein Gold L, Cambazard F, Kalb RE, Lowson D, Bang B, Griffiths CE. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol. 2017 Jan;31(1):119-126. doi: 10.1111/jdv.13859. Epub 2016 Aug 17. | |
| 34397196 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
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A total of 504 subjects were enrolled, 41 enrolled subjects were not randomised. 463 subjects were randomised as follows: 185 subjects to LEO 90100, 188 to calcipotriol BDP gel, 47 to foam vehicle, and 43 to gel vehicle
First Subject First Visit: 30-Jun-2014 Last Subject Last Visit: 04-Mar-2015
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 90100 | LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks |
| FG001 | Aerosol Foam Vehicle | Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks |
| FG002 | Calcipotriol BDP Gel | Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks |
| FG003 | Gel Vehicle | Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 90100 | LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks LEO 90100 aerosol foam |
| BG001 | Aerosol Foam Vehicle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Treatment Success According to the PGA | To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris. Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA). 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline. | Posted | Number | percentage of subjects | 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel |
|
Day 0 until week 12
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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 90100 | LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks LEO 90100 aerosol foam |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (15.1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) |
None reported
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 44945888 | ctr.disclosure@leo-pharma.com |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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|
| Calcipotriol BDP gel | Drug |
|
| Gel vehicle | Drug |
|
Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success. 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline. |
| From Baseline to Week 12 |
| Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group). | Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine). | Baseline to Week 4 |
| Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel). | Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine). | Baseline to Week 4; Baseline to Week 8 |
| Veverka KA, Hansen JB, Yaloumis M, Kircik L, Stein Gold L. Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials. J Drugs Dermatol. 2021 Aug 1;20(8):822-828. doi: 10.36849/JDD.5743. |
| 32785881 | Derived | Iversen L, Kurvits M, Snel-Prento AM, Menter A. Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA >/= 3: Post-Hoc Analysis From Three Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Oct;10(5):1111-1120. doi: 10.1007/s13555-020-00419-2. Epub 2020 Aug 12. |
| 28236223 | Derived | Paul C, Leonardi C, Menter A, Reich K, Gold LS, Warren RB, Moller A, Lebwohl M. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study. Am J Clin Dermatol. 2017 Jun;18(3):405-411. doi: 10.1007/s40257-017-0258-0. |
Clinical Trials at LEO Pharma |
Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
Aerosol foam vehicle
| BG002 | Calcipotriol BDP Gel | Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks Calcipotriol BDP gel |
| BG003 | Gel Vehicle | Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks Gel vehicle |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Calcipotriol BDP Gel | Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks |
|
|
|
| Secondary | Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel. | Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel. | Posted | Number | percentage of subjects | Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel |
|
|
|
|
| Secondary | Time to 'Treatment Success' According to PGA. | Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success. 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline. | Posted | Median | Inter-Quartile Range | weeks | From Baseline to Week 12 |
|
|
|
|
| Secondary | Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group). | Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Week 4 |
|
|
|
|
| Secondary | Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel). | Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to Week 4; Baseline to Week 8 |
|
|
|
|
| 4 |
| 185 |
| 62 |
| 185 |
| EG001 | Aerosol Foam Vehicle | Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks Aerosol foam vehicle | 0 | 47 | 25 | 47 |
| EG002 | Calcipotriol BDP Gel | Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks Calcipotriol BDP gel | 3 | 188 | 60 | 188 |
| EG003 | Gel Vehicle | Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks Gel vehicle | 1 | 43 | 28 | 43 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.1) |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (15.1) |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (15.1) |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (15.1) |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (15.1) |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (15.1) |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (15.1) |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (15.1) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (15.1) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) |
|
| Hypertension | Vascular disorders | MedDRA (15.1) |
|
| Application site pruritus | General disorders | MedDRA (15.1) |
|
| Headache | Nervous system disorders | MedDRA (15.1) |
|
| Sinusitis | Infections and infestations | MedDRA (15.1) |
|
| Gastroenteritis | Infections and infestations | MedDRA (15.1) |
|
| Tooth abscess | Infections and infestations | MedDRA (15.1) |
|
| Intertrigo candida | Infections and infestations | MedDRA (15.1) |
|
| Cellulitis | Infections and infestations | MedDRA (15.1) |
|
| Nail infection | Infections and infestations | MedDRA (15.1) |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (15.1) |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (15.1) |
|
| Eythema | Skin and subcutaneous tissue disorders | MedDRA (15.1) |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (15.1) |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (15.1) |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.1) |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (15.1) |
|
| Influenza like illness | General disorders | MedDRA (15.1) |
|
| Application site pain | General disorders | MedDRA (15.1) |
|
| Feeling cold | General disorders | MedDRA (15.1) |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (15.1) |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) |
|
| Vitamin D decreased | Investigations | MedDRA (15.1) |
|
| Haematoma | Vascular disorders | MedDRA (15.1) |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (15.1) |
|
| Angina pectoris | Cardiac disorders | MedDRA (15.1) |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (15.1) |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) |
|
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.