Chronic plaque type psoriasis of mild to moderate severity, at least one plaque with a treatment area of approximately 25 - 50 cm2 MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: CEP-701 cream formulation, 0.1 %
Pharmaceutical Form: Cream
INN or Proposed INN: Lestaurtinib
CAS Number: 111358-88-4
Current Sponsor code: CEP-701 cream formulation, 0.1 %
Concentration
Sponsors
Perrigo Israel Pharmaceuticals Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a patient in the study: • male patients aged 18 years or older; • patients with psoriasis vulgaris in a chronic stable phase and at least one plaque with a treatment area of approximately 25 - 50 cm2 and mild to moderate severity; • the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • sexually active males should use condom with intravaginal spermicide; male patients have to use contraception for a minimum of two days after last treatment (over 5 elimination half lives of CEP-701 which is 7 hours). The female partners of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), or condom with intravaginal spermicide; • 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: Patients are to be excluded from the study when one or more of the following conditions are met: • patients who require systemically acting medications for the treatment of psoriasis, which might counter or influence the study objectives, e.g. corticosteroids, cytostatics; • local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks) on the plaques to be treated; • systemic treatment with antipsoriatics in the three months preceding and during the study; • treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. ß-blocker, antimalarial and lithium drugs within two weeks before the beginning of the study and during the study; • known allergic reactions to the active ingredients or other components of the study preparations, occlusive dressing, or test chambers; • evidence of drug abuse; • UV-therapy within four weeks before beginning and during the study and extensive natural UV-exposure; • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • treatment with an investigational product/device in another clinical trial in the four weeks preceding and during the study; • in the opinion of the investigator or physician 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; • patient is institutionalized because of legal or regulatory order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Antipsoriatic efficacy and safety of new topical CEP-701 cream formulations will be evaluated in patients with psoriasis vulgaris.;Secondary Objective: ;Primary end point(s): Change from baseline in local PASI | — |
Countries
Germany
Outcome results
None listed