E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with fat located in the treatment area (hypogastrium) |
Pacientes con grasa localizada en el área de tratamiento (hipogastrio) |
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E.1.1.1 | Medical condition in easily understood language |
Subjects with fat located in the hypogastrium |
Pacientes con grasa localizada en el hipogastrio |
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E.1.1.2 | Therapeutic area | Not possible to specify |
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 |
Safety: Evaluate the safety of transcutaneous, intra-adipose injections of Belkyra™ in the hypogastric area, assessed by adverse event reports and clinical evaluation of the treated area (Hypogastrium). |
Seguridad: Evaluar la seguridad de las inyecciones percutáneas intraadiposas de Belkyra™ en la región hipogástrica mediante la evaluación de acontecimientos adversos y la evaluación clínica del área tratada (hipogastrio). |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of Belkyra™ using 0.2 ml/cm2 for reduction of the localized fat of the hypogastrium, based on caliper, ultrasound and 3D camera.
- Patient Related Outcomes measures (PROM), obtained by a satisfaction scale.
- Relationship between dosage and reduction of thickness measured by ultrasound and 3D camera. |
- Evaluar la eficacia de Belkyra ™ usando 0.2 ml / cm2 para la reducción de la grasa localizada del hipogastrio, basada en calibrador, ultrasonido y cámara 3D.
- Medidas de resultados relacionados con el paciente (PROM), obtenidas por una escala de satisfacción.
- Relación entre dosificación y reducción de grosor medida mediante ultrasonido y cámara 3D. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects with fat located in the treatment area (hypogastrium).
2. Subjects with dissatisfaction with fat located in that area (hypogastrium).
3. Males or non-pregnant or non-breastfeeding females from 25 to 50 years.
4. Stable body weight in the last 6 months, with no intention of making changes in diet or sport in the next months.
5. BMI between 18 and 25 kg/cm2.
6. Expected to comply with and understand the visit schedule and the protocol tests.
7. Subject without any serious disease that could interfere the administration of the product.
8. Subjects willing to sign the informed consent form for the study’s participation before first dose is administered. |
1. Sujetos con grasa localizada en el área de tratamiento (hipogastrio).
2. Sujetos con insatisfacción con la grasa localizada en esa área (hipogastrio).
3. Hombres o mujeres no embarazadas y que no amamantan de 25 a 50 años.
4. Peso corporal estable en los últimos 6 meses, sin la intención de realizar cambios en la dieta o el deporte en los próximos meses.
5. IMC entre 18 y 25 kg / cm2.
6. Se espera que cumpla y comprenda el cronograma de visitas y las pruebas de protocolo.
7. Sujeto sin ninguna enfermedad grave que pueda interferir con la administración del producto.
8. Sujetos dispuestos a firmar el formulario de consentimiento informado para la participación del estudio antes de que se administre la primera dosis. |
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E.4 | Principal exclusion criteria |
1. History of any intervention to treat hypogastric fat (eg, liposuction, surgery or lipolytic agents).
2. Subjects with known coagulation disorders or that are being treated with anticoagulation therapy.
3. Any medical condition (eg, respiratory, cardiovascular, hepatic, neurological disease or thyroid dysfunction) that could interfere with assessment of safety or efficacy or compromise the subject’s ability to perform study procedures or give informed consent.
4. History of sensitivity or allergy to any component/excipient of the study drug.
5. Subjects participating in other clinical trials in the last 3 months.
6. Fertile women of childbearing potential (WCBP) not willing to use double barrier methods of contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during the trial and 90 days after the end of treatment. Male patients whose partners are not willing to use double-barrier methods of contraception. |
1. Antecedentes de cualquier intervención para tratar la grasa hipogástrica (p. Ej., Liposucción, cirugía o agentes lipolíticos).
2. Sujetos con trastornos de la coagulación conocidos o que están siendo tratados con terapia de anticoagulación.
3. Cualquier afección médica (p. Ej., Respiratoria, cardiovascular, hepática, neurológica o disfuncional de la tiroides) que pueda interferir con la evaluación de la seguridad o eficacia o comprometer la capacidad del sujeto para realizar procedimientos de estudio o dar su consentimiento informado.
4. Historial de sensibilidad o alergia a cualquier componente / excipiente del medicamento del estudio.
5. Sujetos que participan en otros ensayos clínicos en los últimos 3 meses.
6. Mujeres en edad fértil (WCBP) no dispuestas a utilizar métodos anticonceptivos de doble barrera (abstinencia, anticonceptivos orales, dispositivo intrauterino o método anticonceptivo de barrera junto con gelatina espermicida o estéril quirúrgicamente) durante el ensayo y 90 días después del final del ensayo. Pacientes masculinos cuyas parejas no están dispuestas a usar métodos anticonceptivos de doble barrera. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the safety of transcutaneous, intra-adipose injections of Belkyra™ in the hypogastric area, evaluated by adverse events and clinical evaluation of treated area.
The adverse events reported by subjects in each visit will be collected in the medical history and in the CRF.
In addition, in each visit, investigator will evaluate the treated area (hypogastrium) in order to find out if subject shows any of the following characteristics: edema, bruising, erythema, hyperpigmentation, hypopigmentation, induration, numbness, pain, paresthesias, disesthesias, irregularities (dimples). |
La variable principal es la seguridad de las inyecciones transcutáneas intra-adiposas de Belkyra ™ en el área hipogástrica, evaluadas por eventos adversos y evaluación clínica del área tratada.
Los eventos adversos informados por los sujetos en cada visita se recogerán en el historial médico y en el CRF.
Además, en cada visita, el investigador evaluará el área tratada (hipogastrio) para determinar si el sujeto muestra alguna de las siguientes características: edema, hematomas, eritema, hiperpigmentación, hipopigmentación, induración, entumecimiento, dolor, parestesias, disestesias, irregularidades (hoyuelos). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
None subject will receive more than 4 treatment sessions, no more than 0.2 ml for any individual injection and no more than 10 ml per area (half abdomen) accounting for 20 ml in total.
Study will last maximum 24 weeks. |
Ninguno de los sujetos recibirá más de 4 sesiones de tratamiento, no más de 0,2 ml para una inyección individual y no más de 10 ml por área (medio abdomen), lo que representa 20 ml en total.
El estudio durará un máximo de 24 semanas. |
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E.5.2 | Secondary end point(s) |
- To evaluate the efficacy of Belkyra in the reduction of localized fat of the hypogastrium (reduction in mm of the circumference of the treated zone) evaluated by caliper, ultrasound and 3D camera.
- To measure the subject satisfaction using the Patient Reported Outcomes Measure scale (PROM) (Scale from 0 to 4, being 0: very dissatisfied: 1: somewhat dissatisfied; 2: neutral; 3: somewhat satisfied; 4: very satisfied).
- To measure the relationship between dosage and reduction of thickness evaluated by ultrasound and 3D camera. |
- Evaluar la eficacia de Belkyra en la reducción de la grasa localizada del hipogastrio (reducción en milímetros de la circunferencia de la zona tratada) evaluada mediante calibrador, ultrasonido y cámara 3D.
- Medir la satisfacción del sujeto utilizando la Escala de Medida de Resultados Informados del Paciente (PROM) (Escala de 0 a 4, siendo 0: muy insatisfecho: 1: algo insatisfecho, 2: neutral, 3: algo satisfecho, 4: muy satisfecho).
- Medir la relación entre la dosificación y la reducción del grosor evaluada por ultrasonido y cámara 3D. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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 | No |
E.8.2.3 | Other | No |
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 | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |