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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003058-25 |
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The purpose of the study is to compare the 3 ointment formulations containing LEO 29102 plus calcipotriol and Daivonex® ointment and Diprosone® ointment and to compare LEO 29102 plus calcipotriol to LEO 29102 alone and to calcipotriol alone in the same ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 29102 plus calcipotriol | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment | Drug | once daily application, 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to end of treatment in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration). | TCS range from 0 (all symptoms absent) to 9 (all symptoms severe) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical criteria: - Change from baseline in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits, - Change from baseline in Total Clinical Score (TCS) at individual visits. | 4 weeks | |
| Ultrasonography: Change from baseline to end of treatment in lesion thickness (total and echo-poor band) measured by ultrasound. |
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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 for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:
Subjects using one of the following topical drugs for the treatment of psoriasis within two 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 to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to the 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 and/or subject interview.
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 product(s).
Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis on the test areas.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Queille-Roussel, MD | Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPCAD - Centre de Pharmacologie Clinique Appliquée à la Dermatologie | Nice | 06202 | France |
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| Ointment B: LEO 29102 2.5 mg/g ointment | Drug | once daily application, 4 weeks |
|
| Ointment C: Calcipotriol 50 µg/g ointment | Drug | once daily application, 4 weeks |
|
| Ointment D: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment | Drug | once daily application, 4 weeks |
|
| Ointment G: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment | Drug | once daily application, 4 weeks |
|
| Daivonex® ointment | Drug | once daily application, 4 weeks |
|
| Diprosone® ointment | Drug | once daily application, 4 weeks |
|
| 4 weeks |
| NIR spectroscopy: Change from baseline to Day 15 and end of treatment in the ratio between the peaks at 6900 cm-1 and at 5200 cm-1, the width of the peak at 6900 cm-1 and the calculated severity score | 4 weeks |
| ID | Term |
|---|---|
| C055085 | calcipotriene |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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