THERAVEX® REGENERA Tissue Care Plus for Hair Regeneration and Follicular Microenvironment Modulation

NCT07615608 | Completed

• 1 other identifier: Son-Med-24-7-PD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia; Alopecia; Hair Loss; Non-scarring Alopecia; Hair Transplantation

Keywords

THERAVEX; THERAVEX TECHNOLOGY; THERAVEX REGENERA TISSUE CARE PLUS

Outcome Measures

Primary Outcomes (2)

• Follicular Density Assessment

  Quantitative evaluation of changes in follicular density following regenerative scalp support procedures using standardized trichoscopic imaging and digital follicular counting.

  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.

  Baseline, 1 month, 3 months, 6 months, and 12 months]

Study Arms (2)

THERAVEX Regenerative Support

ACTIVE COMPARATOR

Sterile bioactive mineral-ionic regenerative solution used as supportive therapy during hair restoration and regenerative scalp procedures.

Other: Standard Hair Restoration Care

Standard Hair Restoration Care

ACTIVE COMPARATOR

Participants undergoing conventional hair restoration and postoperative scalp care procedures without THERAVEX® regenerative support.

Other: Standard Hair Restoration Care

Interventions

Standard Hair Restoration Care OTHER

Conventional follicular transplantation and postoperative scalp care performed according to routine clinical practice.

Standard Hair Restoration Care; THERAVEX Regenerative Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older Diagnosis of androgenetic alopecia Candidates for hair restoration procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Biointelligent Technology Systems SL: lead

Study Sites (1)

Biointelligent Technology Syst

Barcelona, 08009, Spain

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments, photographic evaluations, and longitudinal scalp comparisons were performed using standardized comparative evaluation methods in order to reduce observational bias whenever feasible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: July 20, 2024
• Primary Completion: November 10, 2024
• Study Completion: December 20, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)