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The purpose of this trial is to compare the efficacy of treatment with LEO 90100 to that of treatment with vehicle for up to 4 weeks in subjects with psoriasis vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 90100 | Experimental | LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) |
|
| Vehicle | Placebo Comparator | Aerosol foam vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 90100 | Drug |
| ||
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success According to IGA | Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4. The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| m-PASI at Week 4 | The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst). |
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Inclusion Criteria:
Exclusion Criteria:
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 nonmarketed 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.
PUVA therapy within 4 weeks prior to randomisation.
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.
Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the trial.
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
Previously randomised in this trial or any previously conducted trial of LEO 90100.
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| Name | Affiliation | Role |
|---|---|---|
| Craig Leonardi | Central Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Dermatology | St Louis | Missouri | 63117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34397196 | Derived | 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. |
| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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Prior to randomisation, the subject entered a washout phase (if required) where anti-psoriatic treatment and other relevant medication/treatments were discontinued as defined by the exclusion criteria. The wash-out/screening phase could last for up to 4 weeks, depending on which disallowed treatments the subject received.
First Subject First Visit: 17-Jun-2013 Last Subject Last Visit: 02-Oct-2013
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| ID | Title | Description |
|---|---|---|
| FG000 | LEO 90100 | LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) |
| FG001 | Vehicle | Aerosol foam vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LEO 90100 | LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) |
| BG001 | Vehicle | 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 IGA | Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4. The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe | All randomised subjects were included in the full analysis set and analysed for efficacy. | Posted | Number | percentage of subjects | 4 weeks |
|
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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 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Substance induced psychotic disorder | Psychiatric disorders | MedDRA (16.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 44945888 | ctr.disclosure@leo-pharma.com |
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|
| 4 weeks |
| m-PASI at Week 1 | The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst). | 1 week |
| 27714595 | Derived | Stein Gold L, Villumsen J, Rosen M. Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam is Effective, Independent of Body Mass Index and the Extent and Severity of Psoriasis. Dermatol Ther (Heidelb). 2016 Dec;6(4):667-673. doi: 10.1007/s13555-016-0147-0. Epub 2016 Oct 6. |
| 26659941 | Derived | Leonardi C, Bagel J, Yamauchi P, Pariser D, Xu Z, Olesen M, Osterdal ML, Stein Gold L. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST). J Drugs Dermatol. 2015 Dec;14(12):1468-77. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Aerosol foam vehicle
|
|
|
| Secondary | m-PASI at Week 4 | The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst). | All randomised subjects were included in the full analysis set and analysed for efficacy. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 4 weeks |
|
|
|
|
| Secondary | m-PASI at Week 1 | The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI). m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI. The m-PASI score range from 0 (best) to 64.8 (worst). | All randomised subjects were included in the full analysis set and analysed for efficacy. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 1 week |
|
|
|
|
| 2 |
| 323 |
| 18 |
| 323 |
| EG001 | Vehicle | Aerosol foam vehicle | 0 | 103 | 15 | 103 |
| Bipolar disorder | Psychiatric disorders | MedDRA (16.0) |
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| Application site pain | General disorders | MedDRA (16.0) | General disorders and administration site conditions |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) |
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| Nausea | Gastrointestinal disorders | MedDRA (16.0) |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) |
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| Blood pressure increased | Investigations | MedDRA (16.0) |
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| Eye infection | Infections and infestations | MedDRA (16.0) |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (16.0) |
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| Streptococcal infection | Infections and infestations | MedDRA (16.0) |
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| Application site dryness | General disorders | MedDRA (16.0) |
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| Application site erosion | General disorders | MedDRA (16.0) |
|
| Application site erythema | General disorders | MedDRA (16.0) |
|
| Application site oedema | General disorders | MedDRA (16.0) |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (16.0) |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (16.0) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (16.0) |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) |
|
LEO acknowledges the investigators' right to publish the results of the trial, irrespective of outcome. Pubs/presentations by investigator(s) shall not be made before the results of a joint publication is public. 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.