Psoriasis vulgaris lesions located on the arms, legs or trunk. MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Daivobet® ointment
Pharmaceutical Form: Ointment
INN or Proposed INN: Calcipotriol hydrate
CAS Number: 147657-22-5
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject having understood and signed and informed consent form, age 18 years or above, subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have been stable for at least 1 month prior to inclusion and must have a size suitable for application of 6 different products. Subject with psoriasis lesions (plaques) assessed by a Total Clinical Score (sum of scores of erythema, scaling and infiltration) of 4 to 9 inclusive but each individual item = 1. Female subject of childbearing potential using a reliable form of contraception during the course of the study (oral contraceptive pill, intrauterine device, contraceptive patches, implantable con-traception, condoms) or female of non-childbearing potential (i.e. post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy or tubal section/ligation). Female subject of childbearing potential with a negative urinary pregnancy test before the enrolment into the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female who is pregnant, of child-bearing potential and wishing to become pregnant during the study, or are breast feeding 2. Subject using one of the following systemic drugs within 12 weeks prior to study drug administration: - Systemic corticosteroids - Immunomodulators - Antiproliferative drugs (e.g.methotrexate) - Systemic retinoids - Biological therapies (marketed or not marketed) with a possible effect on psoria- sis (e.g. alefacept, efalizumab, etanercept, infliximab) Note: Treatment with ß-blockers is allowed if the treatment has been initiated at least three months be- fore the study start and if no sign of aggravation of the psoriasis has been detected that can be attributed to this treatment. 3. Subject using one of the following topical drugs for the treatment of psoriasis within four weeks before prior to study drug administration - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy 4. Subject using one of the following topical drugs for the treatment of psoriasis within two weeks before prior to study drug administration - WHO group I-II corticosteroids - Topical retinoids - Vitamin D analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy Use of a neutral emollient is allowed on psoriasis plaques not involved in the study. On the target plaques it should not have been used at least one week before the study start. 5. Subject who has 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 last 3 months before baseline 6. Subject with current participation in any other interventional clinical trial. 7. Subject with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. 8. Subject with any of the following conditions present on the psoriatic areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infec- tions and atrophic skin. 9. Subject with a history of serious allergy, allergic skin rash or sensitivity to any compo- nent of investigational products or formulations being tested. 10. Subject with any contraindication to skin biopsy procedures: e.g. allergy to lidocaïne or other anaesthetics, coagulation disorders, treatment with anticoagulant drugs, wound heal- ing disorders, vagal hypertonia or faintheartness, 11. Subject with a history of sero positivity to hepatitis B, C, HIV 12. Subject with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis. 13. Subject foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit. 14. Subject impossible to contact in case of emergency. 15. Subject previously randomized in this trial. 16. Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state). 17. Subject under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate a psoriasis plaque test using two (2) investigational products LEO 80185 gel and LEO 80190 ointment and three (3) active marketed reference products Daivobet® ointment, Daivonex® ointment, and Daivonex® cream and the Daivobet® ointment vehicle.;Secondary Objective: To validate the use of immunohistochemical and histological scoring of biopsy material in conjunction with clinical scoring of the treated areas in the evaluation of treatment effects in psoriatic skin in a the subjects. To obtain information on adverse events for all investigated lesions treated with LEO 80185 gel, LEO 80190 ointment, Daivobet® ointment, Daivonex® ointment, Daivonex® cream and Daivobet® ointment vehicle. ;Primary end point(s): Absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) at end of treatment compared to baseline. | — |
Countries
France
Outcome results
None listed