E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Androgenetic alopecia |
Alopecia androgenética |
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E.1.1.1 | Medical condition in easily understood language |
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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 |
To evaluate the efficacy and safety of using a preparation of autologous plasma rich in growth factors (PRGF-Endoret) in the treatment of androgenetic alopecia. |
Obtener datos preliminares de eficacia y seguridad de la aplicación de plasma rico en factores de crecimiento mediante mesoterapia con pistola DHN 1 electrónica techdent en el tratamiento de la alopecia androgenética masculina y femenina |
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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 |
* Androgenetic alopecia according to the following scales:
Men: Hamilton/Norwood Scale: grades II-VI Women: Ludwig Scale grades I-II.
* Possibility of follow-up during the study |
* Alopecia androgenética atendiendo a las siguientes escalas: Hombres: Escala Hamilton/Norwood: grados II-VI Mujeres: Escala Ludwig grados I-II.
* Posibilidad de seguimiento durante el estudio |
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E.4 | Principal exclusion criteria |
?No androgenetic alopecia ?Telogen and anagen effluvium ?Active inflammation or infection in the intervention area ?Presence of active systemic infections. ?Background of cancerous or precancerous lesions. ?Background of connective or rheumatic diseases. ?Suffering from any serious blood disorders. ?To have undergone treatments for alopecia in the previous 6 months. ?Previous hair implants ?Intake of drugs that affect hair loss. ?Be undergoing immunosuppressive therapy and/or anticoagulants. ?Known intolerance to mesotherapy. ?Taking contraceptives containing cyproterone acetate. ?Pregnancy ?In general, any limitations that would prevent the proper application of both treatments and the right monitoring of the efficacy variables. |
? Alopecias no androgenéticas ? Efluvios telogénicos y anagénicos. ? Inflamación activa o infecciones en la zona de la intervención. ? Presencia de infecciones sistémicas activas. ? Antecedentes de lesiones cancerosas o precancerosas. ? Antecedentes de conectivopatías o enfermedades reumáticas. ? Sufrir alteración hematológica grave. ? Haber seguido tratamientos para la alopecia en los 6 meses previos. ? Implantes capilares previos. ? Ingesta de fármacos que afecten a la caída del pelo. ? Estar siendo sometido a tratamientos inmunosupresores y/o anticoagulantes. ? Intolerancia conocida a la mesoterapia. ? Toma de anticonceptivos que contengan Acetato de ciproterona. ? Embarazo. ? En general, cualquier limitación que impida tanto la correcta aplicación del tratamiento como el seguimiento de la evolución de las variables de eficacia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Hair density (number of hairs per cm2) |
Densidad de pelo (número de pelos por cm2) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Basal, 1, 2 , and 3 months post-treatment |
Basal, 1, 2 y 3 meses post-tratamiento |
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E.5.2 | Secondary end point(s) |
* Hair Width (micrometers) * Anagen/telogen ratio * Terminal Hair Density * Vellous hair density |
* Grosor del pelo * Anagen/telogen ratio * Densidad de pelo terminal * Densidad de pelo velloso |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Basal, 1, 2 , and 3 months post-treatment |
Basal, 1, 2 y 3 meses post-tratamiento |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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
| 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 | 2 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |