Male or female subjects with chronic plaque psoriasis MedDRA version: 12.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: Valrubicin 1% cream
Product Code: VLD32
Pharmaceutical Form: Cream
INN or Proposed INN: VALRUBICIN
CAS Number: 56124620
Current Sponsor code: valrubicin 1% cream
Concentration unit: % p
Sponsors
Valderm ApS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for the study if all of the following apply: 1. Male or female patient =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from participation if any of the following applies: 1.Patients requiring treatment compulsory; 2.Active skin disease apart from plaque psoriasis or tattoos in the test fields; 3.Psoriasis erythrodermatica, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis; 4.Known or suspected hypersensitivity to the active ingredient or any other ingredient of the study preparations or comparators, occlusive dressing or test chamber; 5.Patients with severe liver and renal diseases; 6.Patients with known dysfunction of the calcium metabolism; 7.Patients with acne, pruritus anogenitalis, rosacea, perioral dermatitis, specific skin problems (skin tuberculosis, syphilic skin diseases), vaccination reactions, skin infections caused by viruses, bacteria or fungi in the test fields (plaques) to be treated; 8.Evidence of drug- or alcohol abuse; 9.Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study; 10.Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the study in the four weeks before or during the study; 11.Participation in any clinical study within the last 30 days prior to the first administration of investigational drug in this study; 12.Known allergic reactions to components of the study preparations or comparators; 13.Local treatment with antipsoriatics (like vitamine D, dithranol, glucocorticosteroids; except for salicylic acid in vaseline) in the 4 weeks preceding and during the study; and any topical antipsoriatic treatment on the plaques to be treated in this study (including corticosteroids) in the 8 weeks preceding and during the study; 14.Systemic treatment with antipsoriatics (e.g. retinoids or immunosuppressive therapy) or therapy with PUVA, selected ultraviolet photo- therapy in the three months preceding and during the study; 15.Treatment with systemic or locally acting medications which might interact with the study drugs or impact the effect thereof (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. b-blocker, antimalarial and lithium drugs within two weeks before the beginning of the study and during the study; 16.Contraindications according to summary of product characteristics of the reference drugs; 17.If in the opinion of the investigator performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent; 18.Patient is institutionalized because of legal or regulatory order; 19.Employees of bioskin, third parties associated with the study, or the study site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of antipsoriatic efficacy of valrubicin cream (0.5 % and 1 %) in patients with psoriasis vulgaris in comparison to vehicle cream;Primary end point(s): Reduction of infiltrate thickness;Secondary Objective: 1. Evaluation of tolerability and safety of valrubicin cream (0.5 % and 1 %) in patients with psoriasis plaque in comparison to vehicle 2.Comparison of the efficacy of valrubicin cream 0.5 % and valrubicin cream 1 % with Daivonex 50 mg/g cream 3.Comparison of the efficacy of varubicin 0.5 % and valrubicin 1 % with Betnesol-V cream, 0.1 % | — |
Countries
Germany
Outcome results
None listed