E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Plaque psoriasis |
Psoriasis en placa |
|
E.1.1.1 | Medical condition in easily understood language |
Psoriais with thickened and white plaques |
Psoriasis en forma de placas engrosadas y blaquecinas |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
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 main objective is to define the relationship that exists between the clinical and microscopic evaluation in a target lesion (changes produced at the tissue and cell level) and the secondary effects evaluated microscopically in the psoriatic plaque after the treatment with clobetasol cream only and with Calcipotriol / Betamethasone dipropionate in foam as the only treatment. |
El objetivo principal es definir la relación que existe entre la evaluación clínica y microscópica en una lesión diana (cambios producidos a nivel tisular y celular) y los efectos secundarios evaluados microscópicamente en la placa psoriásica después del tratamiento con clobetasol crema únicamente y con Calcipotriol/Betamethasone en espuma como único tratamiento. |
|
E.2.2 | Secondary objectives of the trial |
Clinical and microscopic evaluation of the recurrence of the disease after clearance in the different treatment arms of the study. Evaluation of the safety and tolerability of the different treatments of the study. Evaluation of the level of patient satisfaction with the treatment received in the study. |
Evaluación clínica y microscópica de la recurrencia de la enfermedad después del aclaramiento en los diferentes brazos de tratamiento del estudio. Evaluación de la seguridad y tolerabilidad de los distintos tratamientos del estudio. Evaluación del nivel de satisfacción del paciente con el tratamiento recibido en el estudio. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who agree to participate in the study and sign the informed consent (IC). Patients diagnosed clinically and / or histologically from plaque psoriasis. Men or women ≥ 18 years. Patients willing to comply with the requirements of the protocol and with the capacity to do so. Outpatient patients Patients who are candidates for treatment with any of the study medications. |
Pacientes que acepten participar en el estudio y firmen el consentimiento informado (CI). Pacientes diagnosticados clínicamente y/o histológicamente de psoriasis en placa. Hombres o mujeres ≥ 18 años. Pacientes dispuestos a cumplir con las exigencias del protocolo y con capacidad para hacerlo. Pacientes ambulatorios. Pacientes candidatos a recibir tratamiento con cualquiera de los medicamentos del estudio. |
|
E.4 | Principal exclusion criteria |
Hypersensitivity to any of the active principles or any of the excipients that appear listed in the technical data sheet of the study drugs. Erythrodermic, exfoliative or pustular psoriasis. Patients with known disorders in calcium metabolism. Acute renal failure. Acute liver disorders. Facial or genital psoriasis. Patients with viral skin lesions, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis, perioral dermatitis, atrophic skin, atrophic streaks, fragility of skin veins, ichthyosis, acne vulgaris, acne Rosacea, rosacea, ulcers and wounds. Systemic treatment including cyclosporin A, methotrexate and steroids in the last 4 weeks. Patients who have received systemic treatment with biological therapies, commercialized or not, with possible effect on plaque psoriasis during the following periods: - etanercept: 4 weeks before visit 1 (week 0) - adalimumab, alefacept, infliximab: 2 months before visit 1 (week 0) - ustekinumab; 4 months prior to visit 1 (week 0) - experimental products: 4 weeks or 5 half-lives (whichever is longer) prior to visit 1 (week 0) Patients who have received topical treatment in the last 15 days. Patients who have received treatment with phototherapy during the following periods: - PUVA: 4 weeks before visit 1 (week 0) - UV-B: 2 weeks before visit 1 (week 0) History of concomitant serious systemic inflammatory cutaneous diseases. Pregnant or lactating women Patients who have participated in another clinical study in the 30 days prior to randomization. |
Hipersensibilidad a cualquiera de los principios activos o cualquiera de los excipientes que aparecen listados en la ficha técnica de los medicamentos del estudio. Psoriasis eritrodérmica, exfoliativa o pustulosa. Pacientes con trastornos conocidos en el metabolismo del calcio. Insuficiencia renal aguda. Desórdenes hepáticos agudos. Psoriasis facial o genital. Pacientes con lesión viral de la piel, infecciones cutáneas fúngicas o bacterianas, infecciones parasitarias, manifestación en la piel en relación con la tuberculosis, dermatitis perioral, piel atrófica, estrías atróficas, fragilidad de las venas de la piel, ictiosis, acné vulgar, acné rosácea, rosácea, úlceras y heridas. Tratamiento sistémico incluyendo ciclosporina A, metotrexato y esteroides en las últimas 4 semanas. Pacientes que hayan recibido tratamiento sistémico con terapias biológicas, comercializadas o no, con posible efecto sobre la psoriasis en placa durante los siguientes periodos: - etanercept: 4 semanas previas a visita 1 (semana 0) - adalimumab, alefacept, infliximab: 2 meses previos a visita 1 (semana 0) - ustekinumab; 4 meses previos a visita 1 (semana 0) - productos experimentales: 4 semanas o 5 vidas medias (lo que sea más largo) previas a la visita 1 (semana 0) Pacientes que hayan recibido tratamiento tópico en los últimos 15 días. Pacientes que hayan recibido tratamiento con fototerapia durante los siguientes periodos: - PUVA: 4 semanas previas a visita 1 (semana 0) - UV-B: 2 semanas previas a visita 1 (semana 0) Historia de enfermedades cutáneas inflamatorias sistémicas graves concomitantes. Mujeres embarazadas o lactantes. Pacientes que hayan participado en otro estudio clínico en los 30 días previos a la randomización. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the clinical response and microscopic changes of the key identifiers for plaque psoriasis in the different treatment arms (Cal / BD and clobetasol) in adult patients affected by plaque psoriasis and treated for a period of up to 4 weeks. |
Comparación de la respuesta clínica y los cambios microscópicos de los indentificadores clave para la psoriasis en placa en los diferentes brazos de tratamiento (Cal/BD y clobetasol) en pacientes adultos afectados por psoriasis en placa y tratados por un periodo de hasta 4 semanas. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the study (from visit 1 to visit 5) |
A lo largo del estudio (visita 1 a visita 5) |
|
E.5.2 | Secondary end point(s) |
Evaluate and compare the significant clinical and microscopic changes detectable related to side effects during treatment in the 2 arms of the study. To assess and compare the timing and clinical and microscopic characteristics of the recurrence of plaque psoriasis after treatment in the 2 arms of the study. Evaluate the degree of patient satisfaction with the medication after treatment in both arms of the study |
Evaluar y comparar los cambios clínicos y microscópicos significativos detectables relacionados con efectos secundarios durante el tratamiento en los 2 brazos del estudio. Evaluar y comparar el momento y las características clínicas y microscópicas de la recurrencia de la psoriasis en placa después del tratamiento en los 2 brazos del estudio. Evaluar el grado de satisfacción del paciente con el medicamento después del tratamiento en los dos brazos del estudio. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the study (from visit 1 to visit 5) |
A lo largo del estudio (visita 1 a visita 5) |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 clinical trial will end when the last included patient has completed the follow-up visit (visit 5). In case of patients who leave the study prematurely due to recurrence of plaque psoriasis, an attempt will be made to follow up the resolution. In the case of patients who leave the study voluntarily, it will not be possible to follow up. |
El ensayo clínico finalizará cuando el último paciente incluido haya completado la visita de seguimiento (visita 5). En caso de pacientes que abandonen el estudio de forma prematura debido a recurrencia de la psoriasis en placa, se intentará hacer un seguimiento hasta la resolución. En el caso de los pacientes que abandonan el estudio de forma voluntaria, no será posible realizar el seguimiento. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |