Androgenetic AlopeciaNCT07615608
THERAVEX® REGENERA Tissue Care Plus for Hair Regeneration and Follicular Microenvironment Modulation
A study testing Standard Hair Restoration Care in people with Androgenetic Alopecia and Alopecia, run by Biointelligent Technology Systems SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Alopecia, Hair Loss
- What is being tested?
- Standard Hair Restoration Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2024to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older Diagnosis of androgenetic alopecia Candidates for hair restoration procedures
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Standard Hair Restoration Care
- Keywords
- THERAVEX, THERAVEX TECHNOLOGY, THERAVEX REGENERA TISSUE CARE PLUS
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Hair Restoration CareOther
Conventional follicular transplantation and postoperative scalp care performed according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| THERAVEX Regenerative Support | Active comparator | Sterile bioactive mineral-ionic regenerative solution used as supportive therapy during hair restoration and regenerative scalp procedures. Receives: 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. Receives: Other: Standard Hair Restoration Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicular Density Assessment
Quantitative evaluation of changes in follicular density following regenerative scalp support procedures using standardized trichoscopic imaging and digital follicular counting.
Measured: 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.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start20 Jul 2024
- Primary completion10 Nov 2024
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biointelligent Technology Systems SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615608
- Sponsor's protocol ID
- Son-Med-24-7-PD
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not required
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07615608
- Acronym / sponsor ID
- Son-Med-24-7-PD
- Keywords
- THERAVEX, THERAVEX TECHNOLOGY, THERAVEX REGENERA TISSUE CARE PLUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Biointelligent Technology Systems SLIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| THERAVEX Regenerative Support | Active comparator | Other: Standard Hair Restoration CareSterile bioactive mineral-ionic regenerative solution used as supportive therapy during hair restoration and regenerative scalp procedures. |
| Standard Hair Restoration Care | Active comparator | Other: Standard Hair Restoration CareParticipants undergoing conventional hair restoration and postoperative scalp care procedures without THERAVEX® regenerative support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years or older Diagnosis of androgenetic alopecia Candidates for hair restoration procedures
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Hair Restoration CareConventional follicular transplantation and postoperative scalp care performed according to routine clinical practice. | Other | Standard Hair Restoration Care, THERAVEX Regenerative Support |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. not required
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Hair Restoration Care in people with Androgenetic Alopecia and Alopecia, run by Biointelligent Technology Systems SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicular Density Assessment (time frame: Baseline, 1 month, 3 months, 6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.