E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with mild to moderate plaque type Psoriasis vulgaris. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints are: • parathormone (PTH) levels in serum; • calcium levels in serum. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is the last visit of the last subject after the follow-up period. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |