Hair ThinningNCT07221773
Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair
A study testing XVIE in people with Hair Thinning, run by Restore Biologics Holdings, Inc. dba Xtressé at 2 sites in United States.
Trial summary
The goal of this study is to determine how safe and effective it is to improve hair growth using XVIE solution applied on the scalp of women with self-perceived thinning hair. The main aims of this trial are: 1. To confirm using photographic analysis, changes in the quality, volume, and thickness of hair. 2. Read more about this study
- Who is it for?
- Ages 28 to 65 years, women only
- Conditions the study is for
- Hair Thinning
- What is being tested?
- XVIE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Sep 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 28-65 years with self-perceived thinning hair (confirmed by an investigator).
- Ludwig Scale 1 to 2
- Fitzpatrick skin types I to VI.
- Ability and willingness to comply with the study protocol.
- Commitment to using effective contraception throughout the study if of childbearing potential.
Who cannot join
- Pregnancy, nursing, or recent initiation of hormone therapy.
- Change in other hair treatments within 3 months prior to the study.
- Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension).
- History of hair or scalp disorders that could interfere with study results.
- History of keloid formation or poor wound healing
- History of bleeding and/or clotting disorders
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Advanced Dermatology & Cosmetic Surgery
Maitland, Florida, 32751
Kindred Hair & Skin Center
Marriottsville, Maryland, 21104
About this study
Official title: Pilot Study to Evaluate the Efficacy and Safety of Xvie (Human Amniotic Fluid Derived Nanoparticle Solution) Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair
The goal of this study is to determine how safe and effective it is to improve hair growth using XVIE solution applied on the scalp of women with self-perceived thinning hair.
The main aims of this trial are:
Read more
- To confirm using photographic analysis, changes in the quality, volume, and thickness of hair.
- To gauge patient satisfaction with hair changes and application process.
Participants who qualify will complete 5 to 6 visits after voluntary consent has been given. Participant's scalp will be numbed and the XVIE solution will be applied by microneedling. Photographs will be taken at each visit to measure changes in hair volume, thickness, and growth. Every participant will receive active treatment twice over the 4 month period.
Read the detailed description
XVIE is a proprietary, additive-free Human amniotic fluid (hAF) based therapy, containing a diverse array of bioactive molecules including growth factors, cytokines, hyaluronic acid, extracellular matrix proteins, and extracellular vesicles including exosomes. Extensive research have shown the ability of Xvie components to support cellular proliferation, angiogenesis, immune regulation, and matrix remodeling which has the potential to reverse underlying cause of hair loss.
In the study, participants will be asked to complete the following:
- Provide basic personal Information
- Provide a Medical \& Surgical History
- Follow study requirements to avoid certain medication and treatments
- Complete all study visits and follow-up calls
- Complete self-assessments and treatment use logs
- Allow clinical assessment and photographic documentation of treatment.
All participants have the right to refuse further participation in the study at any time.
- Conditions
- Hair Thinning
- Being tested
- XVIE
- Keywords
- hair loss, hair thinning, Alopecia, thin hair, thinning hair
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XVIEOther
Acellular Allogenic Human Amniotic Fluid (hAF)
| Study group | Role | What they receive |
|---|---|---|
| XVIE microneedling process applied to the scalp twice over a 4 month period. | Experimental | XVIE is proprietary, additive-free human amniotic fluid derived product that contains an diverse array of bioreactive molecules including growth factors, cytokines, ECM proteins, exosomes, and hyaluronic acid. Receives: Other: XVIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after multiple treatments with XVIE
Measured: From enrollment to the end of treatment at 4 months
Incidence of Adverse Events associated with Treatment
Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events that occur during the trial within 30 days of microneedling treatment.
Measured: From first treatment until the end of treatment at 4 months.
Secondary outcomes (1)
Hair Density Changes measured by SOCAi
Images will be captured using the the SOCAi system at baseline and Days 30, 60, 90, and 120, to evaluate hair density changes.
Measured: From enrollment to the end of the study at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start29 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study evaluating safety and efficacy
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restore Biologics Holdings, Inc. dba Xtressé
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Y Rayner, MS, Study director, Restore Biologics Holding, Inc dba Xtressé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221773
- Sponsor's protocol ID
- XVIEP-2025-001
- Status last verified
- Nov 2025
- First submitted
- 23 Oct 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Efficacy and Safety of Xvie (Human Amniotic Fluid Derived Nanoparticle Solution) Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair
- ClinicalTrials.gov ID
- NCT07221773
- Acronym / sponsor ID
- XVIEP-2025-001
- Conditions
- Hair Thinning
- Keywords
- hair loss, hair thinning, Alopecia, thin hair, thinning hair
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Restore Biologics Holdings, Inc. dba XtresséIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Oct 2025 (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.
The goal of this study is to determine how safe and effective it is to improve hair growth using XVIE solution applied on the scalp of women with self-perceived thinning hair.
The main aims of this trial are:
- To confirm using photographic analysis, changes in the quality, volume, and thickness of hair.
- To gauge patient satisfaction with hair changes and application process.
Participants who qualify will complete 5 to 6 visits after voluntary consent has been given. Participant's scalp will be numbed and the XVIE solution will be applied by microneedling. Photographs will be taken at each visit to measure changes in hair volume, thickness, and growth. Every participant will receive active treatment twice over the 4 month period.
Detailed description
XVIE is a proprietary, additive-free Human amniotic fluid (hAF) based therapy, containing a diverse array of bioactive molecules including growth factors, cytokines, hyaluronic acid, extracellular matrix proteins, and extracellular vesicles including exosomes. Extensive research have shown the ability of Xvie components to support cellular proliferation, angiogenesis, immune regulation, and matrix remodeling which has the potential to reverse underlying cause of hair loss.
In the study, participants will be asked to complete the following:
- Provide basic personal Information
- Provide a Medical \& Surgical History
- Follow study requirements to avoid certain medication and treatments
- Complete all study visits and follow-up calls
- Complete self-assessments and treatment use logs
- Allow clinical assessment and photographic documentation of treatment.
All participants have the right to refuse further participation in the study at any time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study evaluating safety and efficacy
| Arm | Type | Receives |
|---|---|---|
| XVIE microneedling process applied to the scalp twice over a 4 month period. | Experimental | Other: XVIEXVIE is proprietary, additive-free human amniotic fluid derived product that contains an diverse array of bioreactive molecules including growth factors, cytokines, ECM proteins, exosomes, and hyaluronic acid. |
Who may qualify
- Ages
- 28 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 28-65 years with self-perceived thinning hair (confirmed by an investigator).
- Ludwig Scale 1 to 2
- Fitzpatrick skin types I to VI.
- Ability and willingness to comply with the study protocol.
- Commitment to using effective contraception throughout the study if of childbearing potential.
Key exclusion criteria (6 listed)
- Pregnancy, nursing, or recent initiation of hormone therapy.
- Change in other hair treatments within 3 months prior to the study.
- Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension).
- History of hair or scalp disorders that could interfere with study results.
- History of keloid formation or poor wound healing
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 |
|---|---|---|
| XVIEAcellular Allogenic Human Amniotic Fluid (hAF) | Other | XVIE microneedling process applied to the scalp twice over a 4 month period. |
Primary outcome
Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis
Time frame: From enrollment to the end of treatment at 4 months
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after multiple treatments with XVIE
Incidence of Adverse Events associated with Treatment
Time frame: From first treatment until the end of treatment at 4 months.
Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events that occur during the trial within 30 days of microneedling treatment.
1 secondary outcome
Hair Density Changes measured by SOCAi
Time frame: From enrollment to the end of the study at 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Melissa Y Rayner, MS study director
Restore Biologics Holding, Inc dba Xtressé
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XVIE in people with Hair Thinning, run by Restore Biologics Holdings, Inc. dba Xtressé at 2 sites in United States.
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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 8 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 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis (time frame: From enrollment to the end of treatment at 4 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 8 Jun 2026.