mild/severe plaque psorias MedDRA version: 9.1 Level: SOC Classification code 10040785 MedDRA version: 9.1 Level: LLT Classification code 10037153
Conditions
Interventions
Trade Name: TANTUM
Pharmaceutical Form: Cream
INN or Proposed INN: Benzydamine
Concentration unit: % percent
Concentration type: equal
Concentration number: 3-
Trade Name: TANTUM
Pharmaceutical Form:
Sponsors
ANGELINI
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): prevalence of subjects who, at visit 3, achieve a PASI score reduction of at least 50% compared to baseline assessment | — |
Countries
Italy
Outcome results
None listed