An interventional study of Standard Hair Restoration Care in Androgenetic Alopecia, Alopecia and Hair Loss, sponsored by Biointelligent Technology Systems SL. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Biointelligent Technology Systems SL · Not applicable, Interventional, and Treatment
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.
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.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 20 is below the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Biointelligent Technology Systems SL is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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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
Sterile bioactive mineral-ionic regenerative solution used as supportive therapy during hair restoration and regenerative scalp procedures.
Other: Standard Hair Restoration Care
Participants undergoing conventional hair restoration and postoperative scalp care procedures without THERAVEX® regenerative support.
Other: Standard Hair Restoration Care
Conventional follicular transplantation and postoperative scalp care performed according to routine clinical practice.
Follicular Density Assessment
Quantitative evaluation of changes in follicular density following regenerative scalp support procedures using standardized trichoscopic imaging and digital follicular counting.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Scalp Tissue Response Assessment
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.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months]
Plan to share: No — not required
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Biointelligent Technology Systems SL