E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
mild/severe plaque psorias |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10040785 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037153 |
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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 |
Primary objective: to compare the prevalence of subjects who show a clinically meaningful reduction in a validated measure of disease severity (reduction of at least 50% in PASI score after 28 days of treatment compared to baseline) between treatment and placebo arms. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: to compare validated indexes of clinical outcome using further disease severity scales [PASI (at different cut-offs and as continuous variable), Index Lesions Visual Assessment, VAS for itching] at different time points between treatment and placebo arms. To compare prevalence of relapse and time-to-relapse between treatment and placebo arms. To compare the safety of benzydamine hydrochloride cream between treatment and placebo arms. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Men and women ≥ 18 and ≤ 70 years old. 2) Clinical diagnosis of chronic plaque psoriasis for at least 12 months. 3) Mild to moderate psoriasis defined as PASI score ≤10 and BSA ≤12. 4) Subjects legally capable to give their consent to participate in a clinical study. 5) Women of childbearing potential must agree not to start a pregnancy from the signature of the informed consent up to 30 days after the last administration of the investigational product. 6) Sexually active men must commit not to start a pregnancy with their partner/wife from the first dose of investigational product up to 30 days after the last administration of the investigational product. |
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E.4 | Principal exclusion criteria |
1) Presence of lesions exclusively localized in the head (scalp and/or face), neck, axillary, genital, perineal, inter-gluteal, infra-mammary areas or other body-folds, palmo-plantar areas, nails. 2) Presence of guttate, pustolar, or erythrodermic psoriasis. 3) Presence of any open wound of the skin in the area to be treated with the investigational product. 4) Presence of any concomitant skin disorder potentially interfering with the correct assessment of the outcome measures. 5) History of frequent infections of the skin. 6) History HIV infection, or hepatitis C and B. 7) Known malignancy within the previous 5 years (except treated basal-cell skin cancer). 8) Treatment with drugs known to trigger or exacerbate psoriasis flare-ups (including but not limited to lithium, interferon, anti-malarial drugs, or indomethacin). 9) History of drug or alcohol abuse. 10) History of hypersensitivity or intolerance to benzydamine, any of the ingredients of the medication vehicle, or NSAIDs. 11) Phototherapy within (UVA or UVB based) 3 months prior to the screening visit. 12) Systemic treatments (including but not limited to: cyclosporine, methotrexate, oral retinoids, fumaric acid esters, aciretin, systemic steroids) that in the investigators judgement may be active on psoriatic lesions within 3 months prior to the screening visit. 13) Systemic biologic treatments (including but not limited to: alefacept, efalizumab, adalimumab, etanercept, infliximab) within 4 months prior to the screening visit. 14) Topical treatments other than those tested in the study and moisturizers (used according to the protocol) that at the investigators judgement may be active on psoriatic lesions (including but not limited to: corticosteroids, vitamin D analogues, tazarotene, tacrolimus or pimecrolimus, salicylic acid, anthralin, coal tar or combination of the above) within 1 month prior to the screening visit. 15) Concomitant conditions that in the investigators judgement can jeopardize the safe participation of the subject in the study including but not limited to severe renal or liver failure. 16) Pregnant or nursing women. Female participants who will be positive at the pregnancy test performed at screening. 17) Participation in an investigational clinical study within 3 months prior to the screening visit. 18) Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for study-visits, and improbability of completing the clinical study. 19) Subject is the Investigator or his deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study. 20) Vulnerable subjects (e.g. persons kept in detention). |
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E.5 End points |
E.5.1 | Primary end point(s) |
prevalence of subjects who, at visit 3, achieve a PASI score reduction of at least 50% compared to baseline assessment |
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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 | No |
E.6.4 | Safety | No |
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 | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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
| |
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 | 12 |
E.8.9.1 | In the Member State concerned days | |
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 | 12 |