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

May 29, 2026 updated by: Biointelligent Technology Systems SL

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08009
        • Biointelligent Technology Syst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: THERAVEX Regenerative Support
Sterile bioactive mineral-ionic regenerative solution used as supportive therapy during hair restoration and regenerative scalp procedures.
Other: Standard Hair Restoration Care
Conventional follicular transplantation and postoperative scalp care performed according to routine clinical practice.
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Follicular Density Assessment
Time Frame: 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.
Baseline, 1 month, 3 months, 6 months, and 12 months
Scalp Tissue Response Assessment
Time Frame: 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.
Baseline, 1 month, 3 months, 6 months, and 12 months]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biointelligent Technology Systems SL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Son-Med-24-7-PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not required

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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