E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vulvar Lichen Sclerosus et atrophicus |
Lichen escleroso atrófico vulvar |
|
E.1.1.1 | Medical condition in easily understood language |
Vulvar Lichen |
Liquen vulvar |
|
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 |
Analyze the efficacy of PRGF® in the evolution of quality of life of patients with vulvar lichen sclerosus et atrophicus at six and eight months. |
Analizar la eficacia del PRGF® en la evolución de la calidad de vida de pacientes con liquen escleroso atrófico vulvar (LEA) a los seis y ocho meses. |
|
E.2.2 | Secondary objectives of the trial |
1. Study the evolution of dermatological quality of life at 1 and 3 months. 2. Study the clinical evolution at 1, 3, 6 and 8 months. 3. Study the evolution of pain at 1, 3, 6 and 8 months. 4. Study the global impression of improvement at 1, 3, 6 and 8 months. 5. Characterization of blood hematological parameters and PRGF®. 6. Frequency of recurrences at 6 and 8 months of treatment. 7. Evaluate the safety of PRGF®. |
1. Estudiar la evolución de calidad de vida dermatológica a los 1 y 3 meses. 2. Estudiar la evolución clínica a los 1, 3, 6 y 8 meses. 3. Estudiar la evolución del dolor a los 1, 3, 6 y 8 meses. 4. Estudiar la impresión global de mejora a los 1, 3, 6 y 8 meses. 5. Caracterización de los parámetros hematológicos sanguíneos y de PRGF®. 6. Frecuencia de recidivas a los 6 y 8 meses de tratamiento. 7. Evaluar la seguridad del PRGF®. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age> 18 years - Woman with symptoms associated with LEA confirmed with histological study - Spend 1 month without previous treatment in the affected area as a washing period - Availability of observation during the treatment period - Signature of the informed consent |
- Edad >18 años - Mujer con sintomatología asociada a LEA confirmado con estudio histológico - Estar 1 mes sin tratamiento previo en la zona afectada como periodo de lavado - Disponibilidad de observación durante el periodo de tratamiento - Firma del consentimiento informado |
|
E.4 | Principal exclusion criteria |
- Somatic disease in acute state - Infection in the area of intervention or active systemic infection - History of cancerous or precancerous lesions in the area of intervention - In active treatment with other local treatments in the intervention area - In active treatment with immunosuppressants and / or anticoagulants - History of allergies to blood derivatives - Previous diagnosis of coagulopathies - Regular and continued treatment with NSAIDs - Positive markers for HCV, AfHBs, HIV-I / II or TP - Pregnancy or women of childbearing potential not taking contraceptive measures - Lactating women - Treatment with monoclonal antibodies - Any inability to participate in the study |
- Enfermedad somática en estado agudo - Infección en la zona de intervención o infección sistémica activa - Antecedentes de lesiones cancerosas o precancerosas en la zona de intervención - En tratamiento activo con otros tratamientos locales en la zona de intervención - En tratamiento activo con inmunosupresores y/o anticoagulantes - Antecedentes de alergias a derivados hemáticos - Diagnóstico previo de coagulopatías - Tratamiento habitual y continuado con AINES - Marcadores positivos para VHC, AfHBs, VIH-I/II o TP - Embarazo o mujeres en edad fértil que no tomen medidas anticonceptivas - Mujeres lactantes - Tratamiento con anticuerpos monoclonales - Cualquier incapacidad para participar en el estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evolution of quality of life at 6 and 8 months measured through the Skindex-29 index: validated scale referring to dermatological diseases |
Evolución de la calidad de vida a los 6 y 8 meses medida a través del índice Skindex-29: escala validada referente a enfermedades dermatológicas |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 and 8 months |
A los 6 y 8 meses |
|
E.5.2 | Secondary end point(s) |
1. Evolution of quality of life at 1 and 3 months measured by the Skindex-29 index: validated scale referring to dermatological diseases. 2. Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar sclerosus lichen (CSS): validated scale regarding the diagnosis and response to treatment in front of the LEA. 3. Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS): validated scale referring to pain. 4. Evolution of improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I): validated scale referring to the degree of improvement subjective of the patient. 5. Evolution of clinical improvement at 1, 3, 6 and 8 months through the researcher's global assessment (IGA): validated scale referring to degree of clinical improvement of the pathology observed by a clinical specialist. 6. Frequency of relapses at 6 and 8 months of treatment. |
1. Evolución de la calidad vida a los 1 y 3 meses medida a través del índice Skindex-29: escala validada referente a enfermedades dermatológicas. 2. Evolución de la respuesta al tratamiento a los 1, 3, 6 y 8 meses a través de la escala clínica del liquen vulvar escleroso (CSS): escala validada referente al diagnóstico y respuesta a tratamiento frente al LEA. 3. Evolución del dolor a los 1, 3, 6 y 8 meses medida a través de la escala visual análoga del dolor (VAS): escala validada referente al dolor. 4. Evolución de la mejora a los 1, 3, 6 y 8 meses a través de la impresión global del paciente (PGI-I): escala validada referente al grado de mejora subjetiva del paciente. 5. Evolución de la mejora clínica a los 1, 3, 6 y 8 meses a través de la evaluación global del investigador (IGA): escala validada referente al grado de mejora clínica de la patología objetivada por un especialista clínico. 6. Frecuencia de recidivas a los 6 y 8 meses de tratamiento. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 1 and 3 months 2. 1, 3, 6 and 8 months. 3. 1, 3, 6 and 8 months. 4. 1, 3, 6 and 8 months. 5. 1, 3, 6 and 8 months. 6. 6 and 8 months. |
1. 1 y 3 meses 2. 1, 3, 6 y 8 meses 3. 1, 3, 6 y 8 meses. 4. 1, 3, 6 y 8 meses. 5. 1, 3, 6 y 8 meses. 6. 6 y 8 meses. |
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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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Clovate (Propionato de clobetasol) |
Clovate (Propionate of clobetasol) |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |