volunteers with psoriasis vulgaris in a cronic stable phase and stable plaques with an area sufficient for 3 treatment fields MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: Mometasone cream
Product Code: H527722
Pharmaceutical Form: Cream
INN or Proposed INN: Mometasone Fouroate
CAS Number: 83919-23-7
Concentration unit: % percent
Concentration type: equal
Sponsors
Almirall Hermal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a subject in the study: • men and women aged 18 to 75; • subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for three treatment fields separated by at least 2 cm; • the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner; • written informed consent obtained. 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: Subjects are to be excluded from the study when one or more of the following conditions are met: • subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis; • local treatment with antipsoriatics (like vitamine D, dithranol, glucocorticosteroids; except for salicylic acid in vaseline) in the 4 weeks preceding and/or during the study; and any topical antipsoriatic treatment on the plaques to be treated in this study (including corticosteroids, except for salicylic acid) in the 8 weeks preceding and/or during the study; • systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics in the three months preceding and during the study; • treatment with systemic or locally acting medications which might counter or influence the study aim (medications which are known to provoke or aggravate psoriasis, e.g. beta-blocker, antimalarial drugs, lithium) within eight weeks before the beginning of the study and/or during the study; • known allergic reactions, irritations or sensitivity to the active ingredients or other components of the study preparations or comparators, hypersensitivity against cetylstearyl alcohol; • evidence of drug or alcohol abuse; • pregnancy or nursing; • UV-therapy within four weeks before beginning and during the study; • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • participation in another clinical trial involving pharmaceutical products in the four weeks preceeding and/or during the study; • in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent; • subject is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the non-inferiority of a new topical corticsteroid formulation vs the marketed product Ecural® Fettcreme in a psoriasis plaque test;Secondary Objective: ;Primary end point(s): Primary efficacy variable for this study is the area under the curve (AUC) calculated from the changes to baseline in infiltrate thickness. A secondary endpoint is the superiority of Mometasone cream, 0.1 % mometasone furoate to the active ingredient-free vehicle to Mometasone cream with respect to the AUC of change to baseline in infiltrate thickness. | — |
Countries
Germany
Outcome results
None listed