Patients with mild to moderate plaque type Psoriasis vulgaris. MedDRA version: 8.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Curatoderm® Emulsion
Product Name: Curatoderm® Emulsion
Pharmaceutical Form: Cutaneous emulsion
INN or Proposed INN: Tacalcitol
CAS Number: 93129943
Other descriptive name: Tacalcitol
Co
Sponsors
Hermal Kurt Herrmann GmbH & Co. OHG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria have to be met for inclusion of a patient in the study: • men and women aged 18 years or older; • patients with diagnosis of mild to moderate psoriasis vulgaris on the body (minimum duration 3 months) and willing to treat all psoriatic lesions with Tacalcitol; • patients with lesions where topical therapy alone is sufficient, BSA (body surface area) involvement is 5 - 15 % or PASI 3 - 12; • patient is willing and able to participate in the study as an outpatient, make frequent visits to the study site, and comply with all study requirements, including the following: - Study site visits during the prestudy and treatment phase - application of study medication - pregnancy testing for females of childbearing potential - blood and urine samples; • 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 females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), 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 with severe psoriasis; • patients with psoriasis vulgaris with scalp involvement only; • patients with psoriasis vulgaris only at the elbows and knees; • patients with psoriasis guttata or pustular psoriasis; • patients with other dermatoses interfering with the study aim; • patient has a psychiatric condition on account of which the patient should not participate in the study in the opinion of the investigator; • 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 preceding the study; • known allergic or hypersensitive reactions to components of the study medication; • renal failure (creatinine > 1.2 mg/dl); • increased plasma calcium (> 2.7 mmol/l) or increased plasma phosphate (> 1.45 mmol/l), known hypercalcemia or hyperparathyroid disease; • receiving specific antipsotiatic treatment within 4 weeks prior to the baseline visit or retinoids 12 months prior to baseline, or systemic treatment (like biologicals, fumaric esters) or PUVA respectively within 6 months prior to baseline visit; • patient is taking any medication which could interfere with the study preparation and could influence interactions; oral calcium supplements, vitamin D, parathyroid hormone, calcitonin, NSAID’s (like acetyl salicylic acid, diclophenac, ibuprofen, indometacin), barbiturates, benzodiazepine, phenytoin, biphosphonates, beta blockers, chloroquine, lithium, ACE inhibitors, or interferon; • patients with severe hepatic or cardiac diseases; • concomitant therapy with any anti-psoriatic medication; • history of erythroderma or steroid withdrawal induced exacerbations of psoriasis; • previous treatment failure with Vitamin D3 analogues; • patient is suffering from active chemical dependency or alcoholism, as assessed by the investigator; • pregnancy or nursing; • 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; • subjects who were committed to an institution because of forensic or official/regulatory command/order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate the safety and efficacy of the antipsoriatic Curatoderm® Emulsion in patients with mild to moderate plaque type psoriasis vulgaris.;Secondary Objective: ;Primary end point(s): Primary endpoints are: • parathormone (PTH) levels in serum; • calcium levels in serum. | — |
Countries
Germany
Outcome results
None listed