Alopecia, Androgenetic Alopecia, Hair Loss, Hair Transplantation, Non-scarring Alopecia
Conditions
Keywords
THERAVEX, THERAVEX TECHNOLOGY, THERAVEX REGENERA TISSUE CARE PLUS
Brief summary
To evaluate the safety and clinical performance of THERAVEX® REGENERA Tissue Care Plus as an adjunctive regenerative support therapy in patients undergoing hair restoration procedures and regenerative scalp treatment protocols. This clinical investigation assessed the use of a bioactive mineral-ionic formulation during follicular graft preparation, postoperative scalp care, and regenerative scalp support applications in participants presenting with hair loss and follicular density reduction. Clinical follow-up evaluations included assessment of scalp tissue response, postoperative recovery, follicular density changes, tolerability, and longitudinal photographic documentation under standardized clinical conditions. The study also explored the feasibility of supportive regenerative scalp procedures including Dermapen-assisted and mesotherapy-assisted scalp applications.
Detailed description
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.
Interventions
OTHERStandard Hair Restoration Care
Conventional follicular transplantation and postoperative scalp care performed according to routine clinical practice.
Sponsors
Biointelligent Technology Systems SL
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments, photographic evaluations, and longitudinal scalp comparisons were performed using standardized comparative evaluation methods in order to reduce observational bias whenever feasible
Intervention model description
This study was conducted as a prospective interventional clinical investigation evaluating the use of THERAVEX® REGENERA Tissue Care Plus as an adjunctive supportive therapy during hair restoration and regenerative scalp procedures. The investigation included standardized regenerative support protocols performed in participants undergoing autologous hair transplantation and regenerative scalp treatment approaches. Comparative evaluation was performed through controlled clinical follow-up, longitudinal scalp assessment, postoperative regenerative observation, and standardized photographic documentation under predefined clinical conditions. The study additionally included exploratory regenerative scalp support procedures utilizing topical application, follicular graft conditioning, Dermapen-assisted scalp therapy, and mesotherapy-assisted supportive protocols.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Follicular Density Assessment | Baseline, 1 month, 3 months, 6 months, and 12 months | Quantitative evaluation of changes in follicular density following regenerative scalp support procedures using standardized trichoscopic imaging and digital follicular counting. |
| Scalp Tissue Response Assessment | Baseline, 1 month, 3 months, 6 months, and 12 months] | 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. |
Countries
Spain
Outcome results
None listed