E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of pruritus or uticaria |
Tratamiento de prurito o urticaria |
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E.1.1.1 | Medical condition in easily understood language |
Treatment of itch or urticaria |
Tratamiento del picor o la urticaria |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 |
To evaluate the antipruritic and antiinflamatory efficacy of two streghts of PARENTIDE cream in comparison with PLACEBO cream, after inducing itch and inflammation by the application of histamine on the human skin |
Evaluar la eficacia como antiprurítico de dos concentraciones de PARENTIDE crema respecto a PLACEBO crema, tras la inducción de picor e inflamación por aplicación de histamina sobre la piel humana. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy as antiinflamatory of two strenghts of PARENTIDE cream in comparison with PLACEBO cream, after inducing itch and inflammation by the application of histamine on the human skin - To evaluate the safety of two strenghts of PARENTIDE cream in comparison with PLACEBO cream, after inducing itch and inflammation by the application of histamine on the human skin - Determine if the topic application of PARENTIDE cream reaches the systemic circulation |
- Evaluar la eficacia como antiinflamatorio de dos concentraciones PARENTIDE crema respecto a PLACEBO crema, tras la inducción de picor e inflamación por aplicación de histamina sobre la piel humana - Evaluar la seguridad de dos concentraciones de PARENTIDE crema respecto a PLACEBO crema, tras la inducción de picor e inflamación por aplicación de histamina sobre la piel humana - Valorar si la aplicación tópica de PARENTIDE crema alcanza la circulación sistémica. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Healthy volunteers between 18 and 60 years (included) at the moment of the signature of the Informed Consent. - Volunteers with moderate to severe cutaneous reaction according to VAS (Visual Analogic Scale) reported between 4 and 8, 2 minutes after the induction in the control area at Visit 1. |
- Sujetos sanos entre 18 y 60 años (inclusive) en el momento de firma del Consentimiento Informado. - Sujetos con reacción cutánea moderada a severa según Escala Visual Analógica (EVA o VAS) reportada entre un valor de 4 y 8, a los 2 minutos de la inducción (t2) en la zona control en la Visita 1. |
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E.4 | Principal exclusion criteria |
- Pregnancy or breastfeeding. - Consumption of cannabis, opioids or other drugs in the last month. - Positive urine drug test. - History of neurological, musculoskeletal or mental illness or currently presenting one of these illnesses. - Lack of availability to participate. - Concomitant use of medication that may affect the trial, such as antihistamines, antipsychotics and analgesics, as well as systemic or topical steroid treatment. - Consumption of alcohol or analgesics in the last 72 hours before the study and during the study. - Scars or tattoos in the study area. - Acute or chronic pain. - Allergy, hypersensitivity or any other type of incompatibility with any of the components of the investigational products. - Participation in another study in the week prior to the study or in the last 4 weeks in the case of clinical trials with drugs. - Other conditions or situations that may put the subject at significant risk, that may confound the results of the study, or that may significantly interfere with the participation of patients in the study. |
- Embarazo o lactancia. - Consumo de cannabis, opioides u otras drogas en el último mes. - Test para drogas en orina positivo. - Antecedentes de enfermedad neurológica, musculoesquelética o mental o presentar en la actualidad una de estas enfermedades. - Falta de disponibilidad para participar. - Uso concomitante de medicación que pueda afectar al ensayo como por ejemplo antihistamínicos, antipsicóticos y analgésicos, así como tratamiento sistémico o tópico de esteroides. - Consumo de alcohol o analgésicos en las últimas 72 horas antes del estudio y durante el estudio. - Cicatrices o tatuajes en el área de estudio. - Dolor agudo o crónico. - Alergia, hipersensibilidad o cualquier otro tipo de incompatibilidad con alguno de los componentes de los productos en investigación. - Participación en otro estudio en la semana previa al estudio o en las 4 últimas semanas en el caso de ensayos clínicos con medicamentos. - Otras condiciones o situaciones que puedan poner al sujeto en un riesgo significativo, que pueda confundir los resultados del estudio o que pueda interferir significativamente con la participación de los pacientes en el estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Visual Analogic Scale (VAS) score for itch [0 = no itch; 10 = worst imaginable itch] |
Puntuación en la Escala Visual Analógica (EVA) para el picor [0 (sin picor); 10 (peor picor imaginable)] |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Itch will be evaluated at times 2, 5, 10, 20, 30, 45 and 60 minutes after the skin prick test. |
El picor será evaluado en los tiempos 2, 5, 10, 20, 30, 45 and 60 minutos después del skin prick test. |
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E.5.2 | Secondary end point(s) |
- Registration of the adverse events of the subjects after the application of the products under investigation and evaluation of their intensity, causality and frequency. - Erythema index - Temperature. - Diameter (mm) of the irritated area. - Diameter (mm) of the wheal (wheal). |
- Registro de los acontecimientos adversos de los sujetos tras la aplicación de los productos en investigación y evaluación de su intensidad, causalidad y frecuencia. - Índice de eritema. - Temperatura. - Diámetro (mm) del área irritada. - Diámetro (mm) del habón (pápula). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Erythema index and temperature basal values will be recorded at time -5 min before the treatment. After treatment, there will be recorded a times 2, 5, 10, 20, 30, 45 and 60 minutes after the application of the skin prick test.
Diameters of the irritated area and wheal will be registered at times times 2, 5, 10, 20, 30, 45 and 60 minutes after the application of the skin prick test.
Adverse events will be registered at any time of their outcome and they will be monitored until their resolution. |
Los valores basales de índice de eritema y temperatura se registrarán en el tiempo -5 min antes del tratamiento. Después del tratamiento, se registrarán los tiempos 2, 5, 10, 20, 30, 45 y 60 minutos después de la aplicación de la prueba cutánea.
Se registrarán los diámetros de la zona irritada y la roncha en los tiempos 2, 5, 10, 20, 30, 45 y 60 minutos después de la aplicación de la prueba cutánea.
Los eventos adversos se registrarán en cualquier momento de su aparición y se monitorizaran hasta su resolución. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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
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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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |