E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male androgenetic alopecia |
Hombres con alopecia androgenica |
|
E.1.1.1 | Medical condition in easily understood language |
Common baldness in men |
Calvicie común en hombres |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
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 and Tolerability |
Seguridad y tolerabilidad |
|
E.2.2 | Secondary objectives of the trial |
Efficacy in hair loss reduction |
Eficacia en reducción de la pérdida del cabello |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males over 18 years of age, diagnosed with Sinclair grades I-IV androgenic alopecia, who are not currently undergoing any hair treatment and have not undergone any in the last 3 months. - Understand the purpose of the study and be available for frequent visits to the hospital. Sign the informed consent form. - Males with a partner of childbearing age must agree to use a contraceptive method with the partner for the duration of the study. |
- Varones mayores de 18 años, diagnosticados de alopecia androgénica grados I-IV de Sinclair, que no estén realizando ningún tratamiento capilar en la actualidad ni lo hayan realizado en los últimos 3 meses. - Entender el propósito del estudio y estar disponibles para realizar frecuentes visitas al hospital. Firmar el consentimiento informado. - Los varones con pareja en edad fértil deben comprometerse a utilizar un método anticonceptivo con la pareja durante el tiempo que dure el estudio. |
|
E.4 | Principal exclusion criteria |
- Patients with a history of hypersensitivity to the active ingredient, to other 5-alpha reductase inhibitors. - Patients with severe hepatic insufficiency. - Patients who are currently undergoing capillary treatment or have undergone capillary treatment in the last 3 months. - Patients unable to understand the objective of the study or to give informed consent. - Patients who, in the opinion of the investigator, present any difficulty or situation that would hinder or contraindicate their participation in this study. - Patients with a history of drug addiction and drug addictions. - Patients who are participating in another clinical trial. - Patients whose partner is pregnant. |
- Pacientes con antecedentes de hipersensibilidad al principio activo, a otros inhibidores de la 5-alfa reductasa. - Pacientes con insuficiencia hepática grave. - Pacientes que se estén realizando algún tratamiento capilar en la actualidad o lo hayan realizado en los últimos 3 meses. - Pacientes incapaces de entender el objetivo del estudio o de dar su consentimiento Informado. - Pacientes que en opinión del investigador, presenten alguna dificultad o situación que dificulte o contraindique su participación en este estudio. - Pacientes con antecedentes de drogadicción y toxicomanías. - Pacientes que estén participando en otro ensayo clínico. - Pacientes cuya pareja esté embarazada. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Local adverse events (AEs) and systemic adverse reactions (SAEs) |
Acontecimientos adversos (AA) locales y reacciones adversas sistémicas |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 and 6 months since 1 aplication of drug |
A los 3 y 6 meses desde la primera aplicación del fármaco |
|
E.5.2 | Secondary end point(s) |
- Clinical improvement by standardized macroscopic photographs and by trichoscopic variables with the digital device FotoFinder. - Hair microbiome analysis |
Mejoría clínica mediante fotografías macroscópicas estandarizadas y mediante variables tricoscópicas con FotoFinder. Análisis del microbioma capilar |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
3 and 6 months since 1 aplication of drug |
A los 3 y 6 meses desde la primera aplicación del fármaco |
|
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 | Yes |
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) | No |
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) | No |
E.8.2.2 | Placebo | Yes |
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
|
Last visit of the last subject recruited. |
última visita del última paciente reclutado. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |