Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000153-23 |
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
The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 90100 cutaneous spray ointment | Experimental | LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate). |
|
| LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone | Active Comparator | Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate) |
|
| LEO 90100 Cutaneous Spray, Ointment, Vehicle | Placebo Comparator | LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients. |
|
| Daivobet® Ointment | Active Comparator | Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO90100 cutaneous spray, ointment | Drug | once daily application, 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline | TCS range from 0 (all signs absent) to 9 (all signs severe). | Day 1 (Baseline)/Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Sign Scores | Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline. The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)). Negative changes in mean score represent improvement. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
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 and during the study
Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the study
Use of phototherapy within the following time periods prior to randomisation and during the study:
Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study:
Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the study:
Subjects using emollients on the target plaques within one week before randomisation and during the study
Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study
Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history
Subjects with any of the following conditions present on the test area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin
Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas
History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency)
Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
Subjects with current participation in any other interventional clinical trial, based on interview of the subject
Subjects with known or suspected hypersensitivity to component(s) of the investigational products
Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit
Subjects impossible to contact in case of emergency
Subjects who are known or, in the opinion of the investigator, are unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)
Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation
Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom
Subjects previously randomised in this trial
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine Queille-Roussel, MD | Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 06202 Nice Cedex 3, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) | Nice | Cedex 3 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25708531 | Result | Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Efficacy of an innovative aerosol foam formulation of fixed combination calcipotriol plus betamethasone dipropionate in patients with psoriasis vulgaris. Clin Drug Investig. 2015 Apr;35(4):239-45. doi: 10.1007/s40261-015-0269-7. | |
| Result | Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Antipsoriatic effect of a novel aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis, using a modified psoriasis plaque test. Semin Cutan Med Surg. 2015;34 S1:PA-10. | ||
| Result | Hollesen Basse L, Olesen M, Lacour J, Queille-Roussel C. Enhanced in vitro skin penetration and antipsoriatic effect of fixed combination calcipotriol plus betamethasone dipropionate in an innovative foam vehicle. J Invest Dermatol. 2014;134:S33(abst 192). |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study was conducted with 3 successive individual phases:
First Subject First Visit: 12-MAY-2011 Last Subject Last Visit: 20-JUN-2011
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All subjects received all four treatments:
Four test sites of approximately 5 cm2 were selected on predetermined psoriasis lesions (target plaques), delimited with a disposable circular device and mapped on a drawn figure. The distance between two test sites was at least 2 cm. The products were applied on the four test sites (according to random assignment to specific test sites selected on the psoriasis plaque) once daily 6 days a week (except Sundays) for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate | Drug | once daily application, 4 weeks |
|
| LEO 90100 cutaneous spray, ointment, vehicle | Drug | once daily application, 4 weeks |
|
| Daivobet® ointment | Drug | once daily application, 4 weeks |
|
|
| Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment) |
| Changes in Total Clinical Score (TCS) by Visit | Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline. | Baseline and Days 4, 8, 11, 15, 18, 22, 25 |
| Change From Baseline in Echo-poor Band Thickness at End of Treatment | Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound | Baseline and Day 29 |
| Changes in Total Skin Thickness | Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline | Baseline and Days 8, 15, 22, and 29. |
| COMPLETED |
|
| NOT COMPLETED |
|
Intra-individual baseline analysis population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LEO 90100 Cutaneous Spray, Ointment | Intra-Individual baseline analysis population, all treated with the following four products:
|
| 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 |
|
| 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 | Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline | TCS range from 0 (all signs absent) to 9 (all signs severe). | Intra-individual analysis population | Posted | Mean | Standard Deviation | Scores on a scale | Day 1 (Baseline)/Day 29 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change in Clinical Sign Scores | Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline. The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)). Negative changes in mean score represent improvement. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Total Clinical Score (TCS) by Visit | Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Days 4, 8, 11, 15, 18, 22, 25 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Echo-poor Band Thickness at End of Treatment | Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound | Posted | Mean | Standard Deviation | millimetres | Baseline and Day 29 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Total Skin Thickness | Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline | Posted | Mean | Standard Deviation | millimetres | Baseline and Days 8, 15, 22, and 29. |
|
Not provided
Not provided
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 90100 Cutaneous Spray, Ointment | Intra-Individual baseline analysis population, all treated with the following four products:
| 0 | 24 | 10 | 24 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA (6.1) |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.1) |
| ||
| Headache | Nervous system disorders | MedDRA (6.1) |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 44945888 | ctr.disclosure@leo-pharma.com |
| ID | Term |
|---|---|
| D009824 | Ointments |
| C011175 | betamethasone-17,21-dipropionate |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|