THERAVEX® REGENERA Tissue Care Plus for Hair Regeneration and Follicular Microenvironment Modulation
Prospective Translational Preclinical and Clinical Investigation Evaluating the Regenerative Effects and Safety of THERAVEX® REGENERA Tissue Care Plus on Hair Follicular Regeneration, Extracellular Matrix Modulation, and Follicular Microenvironment Optimization Using Preclinical Murine Models, Hair Transplantation Regenerative Support Protocols, and Exploratory Dermapen-assisted Scalp Regenerative Therapy in Alopecic Patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This clinical investigation was designed to evaluate the clinical performance and safety of THERAVEX® REGENERA Tissue Care Plus as a supportive regenerative therapy in hair restoration and scalp regenerative procedures. Hair loss disorders and follicular density reduction are commonly associated with alterations in the scalp microenvironment, postoperative tissue stress, and impaired regenerative conditions that may influence hair restoration outcomes and postoperative recovery.
THERAVEX® REGENERA Tissue Care Plus is a sterile bioactive mineral-ionic formulation intended for local supportive use during regenerative scalp procedures. The investigational approach focused on evaluating its use as an adjunctive supportive therapy during follicular graft preparation, postoperative scalp care, and regenerative scalp support protocols under standardized clinical conditions.
The investigation included adult participants undergoing autologous hair transplantation procedures as well as participants presenting with non-scarring alopecic conditions requiring regenerative scalp treatment approaches. The investigational device was evaluated in combination with routine clinical hair restoration procedures and supportive regenerative scalp protocols, including topical scalp application, follicular graft conditioning, Dermapen-assisted scalp procedures, and mesotherapy-assisted scalp support techniques.
Clinical follow-up assessments included standardized scalp evaluation, digital photographic documentation, postoperative tissue response assessment, follicular density observation, tolerability monitoring, and longitudinal regenerative scalp follow-up. Participants were monitored throughout the predefined observation period according to standardized clinical evaluation schedules.
The study was conducted to further investigate the feasibility, tolerability, and clinical applicability of extracellular microenvironment supportive approaches in regenerative scalp care and hair restoration procedures.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona, España, 08009
- Biointelligent Technology Syst
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Adults aged 18 years or older Diagnosis of androgenetic alopecia Candidates for hair restoration procedures
Exclusion Criteria:
Active scalp infection or inflammatory scalp disease Cicatricial alopecia or severe scalp pathology Uncontrolled systemic disease or unstable medical condition Pregnancy or breastfeeding Immunosuppressive therapy hypersensitivity to any component of the investigational device
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: THERAVEX Regenerative Support
Sterile bioactive mineral-ionic regenerative solution used as supportive therapy during hair restoration and regenerative scalp procedures.
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Conventional follicular transplantation and postoperative scalp care performed according to routine clinical practice.
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Comparador activo: Standard Hair Restoration Care
Participants undergoing conventional hair restoration and postoperative scalp care procedures without THERAVEX® regenerative support.
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Conventional follicular transplantation and postoperative scalp care performed according to routine clinical practice.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Follicular Density Assessment
Periodo de tiempo: Baseline, 1 month, 3 months, 6 months, and 12 months
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Quantitative evaluation of changes in follicular density following regenerative scalp support procedures using standardized trichoscopic imaging and digital follicular counting.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Scalp Tissue Response Assessment
Periodo de tiempo: Baseline, 1 month, 3 months, 6 months, and 12 months]
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Clinical evaluation of scalp tissue condition following regenerative scalp support procedures using standardized investigator-based assessment of tissue appearance, hydration, erythema, and overall scalp condition.
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Baseline, 1 month, 3 months, 6 months, and 12 months]
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Son-Med-24-7-PD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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