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/g milligram(s)/gram
Concentration type: equal
Conc
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects having understood and signed an informed consent form 2.Either sex 3.Age 18 years or above 4.All skin types 5.Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application of 6 different prod-ucts. The subjects should be asked if their lesions have been stable for at least 1 month prior to inclusion 6.Subjects with, in the opinion of the investigator, stable psoriasis assessed by Total Plaque Score at screening visit and again at visit 2 7.Subjects with psoriasis lesions assessed by a Total Plaque Score (sum of scores of erythema, scaling and infiltration) of 4 to 9 inclusive but each individual item = 1 8.Subjects willing and able to follow all the study procedures and complete the whole study 9.Subjects affiliated to social security system 10.Female subjects -of childbearing potential using a reliable form of contraception for at least 1 month before the study start and during the course of the study (oral contracep-tive pill, intrauterine device, contraceptive patches, implantable contraception, condoms) -or females of non-childbearing potential (i.e. postmenopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral ovariectomy or tubal section/ligation) 11.Female subjects of childbearing potential with a negative urinary pregnancy test. 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.Females who are pregnant, of child-bearing potential and who wish to become preg-nant during the study, or who are breast feeding 2.Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration 3.Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation 4.Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration -Potent or very potent (WHO group III-IV) corticosteroids -PUVA or Grenz ray therapy 5.Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks 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 6.Usage of emollients on the target plaques should be stopped at least one (1) week before the study start 7.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 last 4 weeks before randomisation 8.Subjects with current participation in any other interventional clinical trial based on interview of the subject 9.Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular pso-riasis 10.Subjects with any of the following conditions present on the test area: viral (e.g. her-pes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic in-fections and atrophic skin 11.Subjects with a history of serious allergy or known sensitivity to any component of the investigational products or formulations being tested 12.Subjects with known/suspected ongoing hypercalcemia 13.Subjects with known severe hepatic and renal insufficiency 14.Subjects with a history of sero positivity to HIV or active hepatitis B, C 15.Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, pe-rioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas 16.Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis 17.Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two (2) weeks preceding the screening visit 18.Subjects impossible to contact in case of emergency 19.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) 20.Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subjects deprived of freedom 21.Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the anti-psoriatic effect of: Daivobet® ointment, Diprosalic® ointment, Betnovat® ointment, Dermovat® ointment, Elocon® ointment, and Daivobet® ointment vehicle by evaluation of the clinical scoring and ultrasound skin echography of lesion thickness of psoriasis plaques. ;Secondary Objective: The secondary objective is to obtain information on adverse events for all investigated lesions treated with one of the above mentioned products. ;Primary end point(s): Absolute change in Total Clinical Score of clinical symptoms (sum of erythema, scaling and infiltration) at end of treatment compared to baseline. | — |
Countries
France
Outcome results
None listed