Subjects with a stable phase of chronic psoriasis vulgaris MedDRA version: 14.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: MomeGalen Cream
Pharmaceutical Form: Cream
INN or Proposed INN: Mometasone furoate
CAS Number: 83919-23-7
Current Sponsor code: MomeGalen Cream
Other descriptive name: IMP 1
Concentratio
Sponsors
GALENpharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • men and women aged 18 to 75; • subjects with psoriasis vulgaris in a chronic stable phase; • subjects with stable plaques with an area sufficient for three treatment fields; the target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesion on the knees or elbows cannot be used as a target lesion; • the infiltrate thickness in the target lesion has to be greater than 200 µm; • the physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial; • female volunteers of childbearing potential had either to 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 30 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • 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 trial; and any topical antipsoriatic treatment on the plaques to be treated in this trial (including corticosteroids, except for salicylic acid) in the 8 weeks before first treatment and/or during the trial; • systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics in the three months before first treatment and during the trial; • treatment with systemic or locally acting medications which might have countered or influenced the trial aim (medications which are known to provoke or aggravate psoriasis, e.g. ?-blocker, antimalarial drugs, lithium) within eight weeks before first treatment and/or during the trial; • known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products; • contraindications according to summary of product characteristics of Ecural® Fettcreme; • known non-responders to reference listed drug Ecural® Fettcreme; • evidence of drug or alcohol abuse; • pregnancy or nursing; • UV-therapy within four weeks before first treatment and during the trial; • symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before first treatment and during the trial; • participation in the treatment phase of another clinical trial within the last four weeks prior to first treatment in this clinical trial; • in the opinion of the investigator or physician performing the initial examination the subject should not have participated in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent; • close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH or subject is an employee of sponsor; • subject was institutionalized because of legal or regulatory order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to demonstrate clinical equivalence of MomeGalen Cream (mometasone furoate 0.1 %) to Ecural® Fettcreme (reference drug) in anti-psoriatic efficacy by sonographic measurement of psoriatic infiltrate in subjects with chronic psoriasis vulgaris.;Secondary Objective: The secondary objective is to evaluate the anti-psoriatic efficacy of MomeGalen Cream (mometasone furoate 0.1 %) by clinical assessment in subjects with chronic psoriasis vulgaris. ;Primary end point(s): Changes in psoriatic infiltrate thickness over the treatment period from day 1 to day 12. ;Timepoint(s) of evaluation of this end point: Time period from day 1 to 12, evaluation on days 1, 4, 8 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in psoriatic infiltrate thickness on days 4, 8, and 12; Clinical assessment using a 5-point score on days 4, 8, and 12;Timepoint(s) of evaluation of this end point: Psoriatic infiltrate thickness: days 4, 8, and 12; Clinical assessment: days 4, 8, and 12 | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information Desk
bioskin GmbH
Outcome results
None listed