E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Androgenetic alopecia |
Alopecia androgénica |
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E.1.1.1 | Medical condition in easily understood language |
Hair loss |
Pérdida de cabello |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10068168 |
E.1.2 | Term | Androgenetic alopecia |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 determine whether a daily treatment with P-3074 for 24 weeks increases hair count in men with male pattern baldness (MPB) compared to the vehicle. |
El objetivo principal de este estudio esencial de fase III es determinar si el tratamiento diario con P-3074 durante 24 semanas aumenta el recuento capilar en varones con alopecia androgénica (MPB) en comparación con el tratamiento con el excipiente. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent before starting any study related procedures; 2. Men 18 to 40 years of age; 3. Men with mild to moderate vertex male pattern hair loss according to a modified Norwood/Hamilton classification scale (III vertex, IV or V); 4. Patients willing to have a tattoo in the target area; 5. Outpatients; 6. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; 7. Ability to co-operate with the Investigator and to comply with the requirements of the entire study. |
1. Consentimiento informado por escrito antes de comenzar cualquier procedimiento relacionado con el estudio. 2. Ser varón de 18 a 40 años de edad. 3. Ser varón con alopecia androgénica leve a moderada en la coronilla de acuerdo con la escala de clasificación de Norwood/Hamilton modificada (III-coronilla, IV o V). 4. Pacientes dispuestos a ser tatuados en la zona objetivo. 5. Pacientes ambulatorios. 6. Capacidad de comprender la naturaleza íntegra y el objetivo de este estudio, incluidos los posibles riesgos y efectos secundarios. 7. Capacidad de cooperar con el investigador y cumplir los requisitos de todo el estudio. |
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E.4 | Principal exclusion criteria |
1. Clinically relevant abnormal physical findings which could interfere with the aim of the study; in particular, skin damage such as abrasion, actinic keratosis or any abnormal findings in the scalp; 2. Patients who had had hair transplant surgery or hair weaving; 3. Clinically relevant abnormal laboratory values indicative of physical illness; 4. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study; 5. History of local infections of skin and subcutaneous tissues of the head in the 3-month period before the trial inclusion; 6. Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study; 7. Suspicion of malignancy, including prostate cancer; 8. History of infertility or difficulty fathering children; 9. Patients who wished to father children during the study or whose sexual partner(s) were pregnant; 10. Patients with active seborrheic dermatitis; 11. History of varicocele; 12. Concurrent use of systemic corticosteroids, topical corticosteroids in the balding area studied, anabolic steroids, or over-the-counter "hair restorers"; 13. Use of the following drugs with antiandrogenic properties within 6 months of study entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine, spironolactone, or ketoconazole; 14. Patients who had been treated with any of the following drugs within the past year: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents; 15. Use of finasteride or dutasteride within previous 12 months; 16. Light or laser treatment of scalp within previous 3 months; 17. Participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study; 18. History of drug, alcohol [>2 drinks/day defined according to USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse ( >=10 cigarettes/day). |
1. Hallazgos anómalos de importancia clínica en la piel del cuero cabelludo que podrían interferir con el objetivo del estudio, en concreto: abrasión, queratosis actínica, afecciones inflamatorias o cualquier otra anomalía. 2. Pacientes sometidos a cirugía de trasplante capilar o de implantes capilares. 3. Valores de laboratorio anómalos de importancia clínica indicativos de enfermedades físicas. 4. Hipersensibilidad verificada o presunta al principio activo y/o los componentes de la formulación, antecedentes de reacciones anafilácticas a fármacos o reacciones alérgicas en general, que el investigador considere que podrá afectar a los resultados del estudio. 5. Antecedentes de infecciones locales en la piel y tejidos subcutáneos de la cabeza en los 3 meses anteriores a la inclusión en el estudio. 6. Antecedentes relevantes de afecciones renales, hepáticas, gastrointestinales, cardiovasculares, respiratorias, cutáneas, hematológicas, endocrinas o neurológicas que puedan interferir con el objetivo del estudio. 7. Sospecha de neoplasia, como el cáncer de próstata. 8. Antecedentes de infertilidad o problemas para tener hijos. 9. Pacientes que deseen tener hijos durante el estudio o cuya pareja sexual esté embarazada. 10. Pacientes con dermatitis seborreica activa. 11. Antecedentes de varicocele. 12. Uso concurrente de corticoesteroides sistémicos, corticoesteroides tópicos en el área con calvicie estudiada; esteroides anabolizantes o ?restauradores capilares? de venta libre. 13. Uso de los siguientes fármacos con propiedades antiandrogénicas durante los 6 meses anteriores a la entrada en el estudio: flutamida, acetato de ciproterona, estrógenos, progesterona, cimetidina, espironolactona o ketoconazol. 14.Pacientes que hayan sido tratados con alguno de los siguientes fármacos en el último año: minoxidil (vía tópica u oral), cidovudina, ciclosporina, diazóxido, fenitoína, interferón sistémico, psoralenos, estreptomicina, penicilamina, benoxaprofeno, tamoxifeno, fenotiazina o agentes citotóxicos. 15. Uso de finasterida o dutasterida en los 12 meses anteriores. 16. Tratamiento con luz o láser en el cuero cabelludo en los 3 meses anteriores. 17. Haber participado en la evaluación de cualquier fármaco durante los 3 meses anteriores a este estudio, calculados desde el primer día del mes posterior a la última visita del estudio anterior. 18 .Antecedentes de consumo de drogas o alcohol [>2 bebidas/día de acuerdo con las Pautas alimenticias de la USDA 2010], cafeína (>5 tazas café/té/día) o tabaco (?10 cigarrillos/día). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Hair growth assessed by Target Area Hair Count (TAHC) in the vertex. |
Crecimiento capilar evaluado según el recuento de pelos del área objetivo (TAHC) en la coronilla. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 24 weeks. |
A las 24 semanas. |
|
E.5.2 | Secondary end point(s) |
1. Hair growth assessed by TAHC in the vertex at 12 Weeks; 2. Target Area Hair Width (TAHW) in the vertex at Weeks 12 and 24; 3. Patient assessment of change from baseline in Male Hair Growth Questionnaire (MHGQ) Score at Weeks 12 and 24; 4. Investigator Assessment of Improvement from Baseline to Week 12 and from Baseline to Week 24, assessed for vertex; 5. Blind Assessor Assessment of Improvement from Baseline to Week 12 and from Baseline to Week 24, assessed for vertex; 6. Assessment of sexual function at every visit (Sexual Function Index); 7. Assessment of adverse events (AEs) throughout the study; 8. Assessment of the local tolerability by means of severity scores for skin irritation |
1. Crecimiento capilar evaluado según el TAHC en la coronilla a las 12 semanas. 2. Grosor del pelo en el área objetivo (TAHW) en la coronilla a las 12 y 24 semanas. 3. Evaluación del paciente en el cuestionario sobre crecimiento capilar masculino (MHGQ) a las 12 y 24 semanas. 4. Evaluación del investigador sobre la mejoría desde el valor inicial hasta la semana 12 y desde el valor inicial hasta la semana 24, evaluada para la coronilla. 5. Evaluación del evaluador enmascarado sobre la mejoría desde el valor inicial hasta la semana 12 y desde el valor inicial hasta la semana 24, evaluada para la coronilla. 6. Evaluación de la función sexual en todas las visitas (Índice de actividad sexual). 7. Evaluación de los acontecimientos adversos (AA) durante todo el estudio 8. Evaluación de la tolerabilidad local mediante las puntuaciones de intensidad para la irritación de la piel. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. At 12 Weeks 2. At Weeks 12 and 24 3. At Weeks 12 and 24 4. From Baseline to Week 12 and from Baseline to Week 24 5. From Baseline to Week 12 and from Baseline to Week 24 6. At every visit 7. Throughout the study 8. Throughout the study |
1. A las 12 semanas 2. En semanas 12 y 24 3. En semanas 12 y 24 4. Desde basal a semana 12 y desde basal a semana 24 5. Desde basal a semana 12 y desde basal a semana 24 6. En cada visita 7. A lo largo del estudio 8. A lo largo del estudio |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Germany |
Hungary |
Russian Federation |
Spain |
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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
|
LPLV |
Última vista del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |