E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriasis vulgaris on the scalp |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037157 |
E.1.2 | Term | Psoriasis of scalp |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
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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 primary objective of this study is the comparison of test product versus reference product. Test product should be non-inferior to reference product based on relative reduction from baseline in TSS (Total Sign Score) after 3 weeks of treatment (d 22). |
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E.2.2 | Secondary objectives of the trial |
Non-inferiority of test product to reference product on relative reduction of TSS in comparison to baseline after 1 (d8), and 2 weeks (d15) of treatment. Frequencies of clinically relevant psoriasis reduction (TSS reduction of >50 %, >75 %, >90 %) after 1, 2, and 3 weeks of treatment for test product and reference product. Comparisons for scalp PGA changes to baseline for test and reference product after 1, 2, and 3 weeks of treatment Descriptive statistics for single parameters of TSS (erythema, scaliness, thickness,) for each test product and each assessment time point Subjective assessment of pruritus, and burning/stinging by patients at each assessment time point and for each test product separately. Local tolerability (signs for irritation, 4-point scale) will be assessed at each assessment time point and each test product separately. Patient questionnaire regarding product traits Safety parameters are documented and analyzed during treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Male or female patients 18-75 years of age •Chronic scalp psoriasis for at least 4 months before enrollment in this study oTSS ≥ 4 (at least one sign graded with "2", on each other sign a grade of "1" is required) up to 12 oExtent of scalp psoriasis involving more than 10 % of the total scalp area •All patients must give written informed consent before any assessment is performed. •General good health as determined by investigator based upon results of medical history •Scalp psoriasis is amenable for topical treamtent •Willingness to actively participate in the study and come to scheduled visits •Willingness to discontinue the use of their own topical psoriasis treatment at the scalp •Negative urine pregnancy test (in female patients of child bearing potential) •Reliable methods of contraception which result in a low failure rate (i.e. less than 1% per year) for women of childbearing potential (implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomized partner)
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E.4 | Principal exclusion criteria |
•Patients who need systemic treatment for their body psoriasis •History of hypersensitivity to any of the study drugs or ingredients of the study drugs or to drugs of similar chemical classes •History of malignancy of any organ system •Atrophy of the scalp •Medication: •Systemic treatment that may interfere with the investigational product Corticosteroids, antibiotics 4 weeks prior to study day 1 and during conduct of study Retinoids 6 weeks prior to study day 1 and during conduct of study Vitamin D supplements, hydroxycarbamide, azathioprine, meth-otrexate, cyclosporine 4 weeks prior to study day 1 and during conduct of study Immunomodulators 3 months prior to study day 1 and during conduct of study Treatment with biologicals with a possible effect on scalp psoriasis 6 months prior to study day 1 and during conduct of study Planned initiation of, or changes to concomitant medication that could affect psoriasis (e.g. beta blockers, anti-malaria drugs, lithium)
-Topical treatment of, scalp, face and neck (see table below): Corticosteroids, antibiotics 4 weeks prior to study day 1 and during conduct of study Retinoids 6 weeks prior to study day 1 and during conduct of study Anti-inflammatory substances 2 weeks prior to study day 1 and during conduct of study Vitamin A analogues, Vitamin D analogues, Immunosuppressants, Anthracen derivates 2 weeks prior to study day 1 and during conduct of study Salicylic acid preparations 2 weeks prior to study day 1 and during conduct of study Tar 2 weeks prior to study day 1 and during conduct of study UVB Therapy 2 weeks prior to study day 1 and during conduct of study PUVA Therapy 4 weeks prior to study day 1 and during conduct of study Neutral emollients 1 week prior to study day 1 and during conduct of study -Topical treatment with corticosteroids or immunosuppressants in case more than 20 % of the body surface area is treated -Treatment with any non-marketed drug substance (i.e. an agent which had not yet been made available for clinical use following registration) within 4 weeks prior to study day 1 •Planned use of chemical treatments of the hair (e.g. relaxers, perms or colorings) during the conduct of the study •Shampoos containing corticosteroids within 2 weeks before study day 1 and during the conduct of the study •Diseases: Specific skin diseases (such as tuberculosis or syphilis) Erythrodermic, exfoliative or pustular psoriasis Skin infections caused by bacteria or viruses or fungal skin infection Varicella zoster Skin reactions after immunization Rosaceae, perioral dermatitis Moderate or severe illness within the last two weeks before first exposure Known infectious diseases (e.g. hepatitis or AIDS) Other inflammatory skin diseases that may confound the evaluation of psoriasis •Pregnancy or lactation •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing •Any history of drug addiction or alcoholism in the past 3 years •Patients with poor compliance •Patients, who are inmates of psychiatric wards, prison or state institutions •Participation in a clinical trial within the last 30 days prior to the start of this study •Patients underlying any other restrictions due to the participation in other tests / test institutes •Employees of the study sites or of the Sponsor’s company •If in the opinion of the investigator the patient should not participate in the study for any reason
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints: TSS (Total Sign Score) after a treatment of 3 weeks (calculation of 95 % confidence interval for treatment difference test product to reference on relative changes to baseline)
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
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 | 6 |
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
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The end of the trial is defined as the last visit of the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |