Thin HairNCT07228156
Study to Evaluate Xtresse Serum in Individuals With Thinning Hair
A study testing Xtresse Serum in people with Thin Hair and Hair Loss, run by Restore Biologics Holdings, Inc. dba Xtressé at 3 sites in United States.
Trial summary
The goal of this study is to determine how safe and effective it is to improve hair growth by applying a serum daily on the scalp of men and women with 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 18 to 65 years
- What is being tested?
- Xtresse Serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Dec 2025to Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and Men Aged 18-65 years with self-perceived hair thinning (confirmed by an investigator).
- Fitzpatrick skin Types I to IV
- Ludwig Scale I or II or Norwood Scale 1 to 4 (mild to moderate thinning hair)
- Agree to maintain their current diet, medication, exercise routines, hair shampooing, and color treatment frequency for the duration of the study.
- Ability and willingness to comply with the study protocol including regular visits and product application.
- Written informed consent obtained, including written consent to allow photographs to be used as part of the study data and documentation.
- For females of childbearing potential, a negative pregnancy test at screening.
- Commitment to using effective contraception throughout the study.
Who cannot join
- Pregnancy, nursing, planning to become pregnant.
- Initiation of hormone therapy or changes in hormonal therapy within 6 months prior to enrollment and throughout the study.
- Use of other medical hair loss treatments (e.g. Minoxidil, Dutasteride, Finasteride, laser or light therapy) within 3 months prior to the study and throughout the study.
- Microneedling, PRP, or other physical treatment modality on the scalp within 6 months prior to the study and throughout the study.
- Use of GLP-1 inhibitors (e.g. semaglutide) within 6 months prior to the study and throughout the study.
- Known uncontrolled health conditions (poorly controlled diabetes, hypertension).
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- History of scalp disorders that could interfere with study results.
- Known sensitivity to any of the ingredients in the study medication.
- In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study.
- Subject has any conditions, findings in history, physical exam, or laboratory assessments, which in the opinion of the investigator, would exclude the subject from continuing in this study.
- Treatment with an experimental drug, biologic, or device within 12 weeks of the screening visit.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Root Hair Institute
Bellevue, Washington, 98004
Advanced Dermatology & Cosmetic Surgery
Maitland, Florida, 32751
Kindred Hair and Skin Center
Marriottsville, Maryland, 21104
About this study
Official title: Pilot Study to Evaluate the Efficacy and Safety of Xtresse FR Concentrate Serum in Individuals With Self-Perceived Thinning Hair.
The goal of this study is to determine how safe and effective it is to improve hair growth by applying a serum daily on the scalp of men and women with 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.
- Monitor and report any adverse events associated with the daily usage of Xtressé serum.
Participants who qualify will complete 7 visits after voluntary consent has been given. Participants will be given 9 bottles of serum to use during the study. The product will be applied daily over a 9-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth. Participants will complete a survey in the middle and at the end of the study.
Read the detailed description
In the study, participants will be asked to complete the following:
- Provide basic personal information (including date of birth, gender, race and ethnicity)
- Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight, and pregnancy test)
- Follow study rules such as avoiding certain medications and treatments
- Provide information on any medications, treatments or reactions that started after the study began
- Apply serum daily and complete a treatment log
- Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects
To qualify for this trial, participants must:
- Be an adult between ages of 18-65
- Have consistent self-perceived thinning hair.
- Give voluntary written consent
- Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatment areas
- Allow photographs of the front and top area of the scalp
- Not be pregnant or breast feeding before and during the study and agree to use acceptable forms of birth control
- Confirm they are not sensitive to any of the study treatment ingredients
All photographs of the treatment area collected during the study will be used as study data.
All participants have the right to refuse further participation in the study at any time.
- Conditions
- Thin Hair, Hair Loss, Alopecia, Thinning Hair
- Being tested
- Xtresse Serum
- Keywords
- Xtresse, serum
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xtresse SerumOther
The concentrate serum is powered by proprietary X-3 BioActive Blend and contains plant-based extracts and regenerative compounds not commonly found in existing hair supplements.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Xtresse Concentrate Serum Participants will receive 4-month supply of serum. They will apply serum to their scalp daily and notate usage log. Receives: Other: Xtresse Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in hair density assessed by Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months of application of Xtressé™ serum. Measurements of density as measured hair per cm².
Measured: From enrollment to end of treatment at 4 months
Hair Density changes measured by SOCAi
Images will be captures using 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
Increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after applying Xtressé™ Serum. Measurements of follicular unit vellus/terminal ratio.
Measured: From enrollment to the end of treatment at 4 months
Secondary outcomes (1)
Incidence of Adverse Events associated with treatment
Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events associated with the daily application of serum
Measured: From first treatment until the end of treatment 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 posted14 Nov 2025
- Study start17 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin HairStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restore Biologics Holdings, Inc. dba Xtressé
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Rayner, MS, Study director, Restore Biologics Holdings, Inc dba Xtresse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228156
- Sponsor's protocol ID
- XTRS-SERUM-2025-001
- Status last verified
- Jun 2026
- First submitted
- 12 Nov 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 Xtresse FR Concentrate Serum in Individuals With Self-Perceived Thinning Hair.
- ClinicalTrials.gov ID
- NCT07228156
- Acronym / sponsor ID
- XTRS-SERUM-2025-001
- Conditions
- Thin Hair, Hair Loss, Alopecia, Thinning Hair
- Keywords
- Xtresse, serum
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Restore Biologics Holdings, Inc. dba XtresséIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Nov 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 by applying a serum daily on the scalp of men and women with 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.
- Monitor and report any adverse events associated with the daily usage of Xtressé serum.
Participants who qualify will complete 7 visits after voluntary consent has been given. Participants will be given 9 bottles of serum to use during the study. The product will be applied daily over a 9-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth. Participants will complete a survey in the middle and at the end of the study.
Detailed description
In the study, participants will be asked to complete the following:
- Provide basic personal information (including date of birth, gender, race and ethnicity)
- Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight, and pregnancy test)
- Follow study rules such as avoiding certain medications and treatments
- Provide information on any medications, treatments or reactions that started after the study began
- Apply serum daily and complete a treatment log
- Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects
To qualify for this trial, participants must:
- Be an adult between ages of 18-65
- Have consistent self-perceived thinning hair.
- Give voluntary written consent
- Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatment areas
- Allow photographs of the front and top area of the scalp
- Not be pregnant or breast feeding before and during the study and agree to use acceptable forms of birth control
- Confirm they are not sensitive to any of the study treatment ingredients
All photographs of the treatment area collected during the study will be used as study data.
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
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Other: Xtresse SerumXtresse Concentrate Serum Participants will receive 4-month supply of serum. They will apply serum to their scalp daily and notate usage log. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women and Men Aged 18-65 years with self-perceived hair thinning (confirmed by an investigator).
- Fitzpatrick skin Types I to IV
- Ludwig Scale I or II or Norwood Scale 1 to 4 (mild to moderate thinning hair)
- Agree to maintain their current diet, medication, exercise routines, hair shampooing, and color treatment frequency for the duration of the study.
- Ability and willingness to comply with the study protocol including regular visits and product application.
Key exclusion criteria (11 listed)
- Pregnancy, nursing, planning to become pregnant.
- Initiation of hormone therapy or changes in hormonal therapy within 6 months prior to enrollment and throughout the study.
- Use of other medical hair loss treatments (e.g. Minoxidil, Dutasteride, Finasteride, laser or light therapy) within 3 months prior to the study and throughout the study.
- Microneedling, PRP, or other physical treatment modality on the scalp within 6 months prior to the study and throughout the study.
- Use of GLP-1 inhibitors (e.g. semaglutide) within 6 months prior to the study and throughout the study.
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 |
|---|---|---|
| Xtresse SerumThe concentrate serum is powered by proprietary X-3 BioActive Blend and contains plant-based extracts and regenerative compounds not commonly found in existing hair supplements. | Other | Single Group |
Primary outcome
Increase in hair density assessed by Canfield HairMetrix® Phototrichogram Analysis
Time frame: From enrollment to end of treatment at 4 months
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months of application of Xtressé™ serum. Measurements of density as measured hair per cm².
Hair Density changes measured by SOCAi
Time frame: From enrollment to the end of the study at 4 months
Images will be captures using the SOCAI system at baseline and Days, 30, 60, 90, and 120 to evaluate hair density changes.
Increase in hair 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 applying Xtressé™ Serum. Measurements of follicular unit vellus/terminal ratio.
1 secondary outcome
Incidence of Adverse Events associated with treatment
Time frame: From first treatment until the end of treatment 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
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.
Melissa Rayner, MS study director
Restore Biologics Holdings, Inc dba Xtresse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xtresse Serum in people with Thin Hair and Hair Loss, run by Restore Biologics Holdings, Inc. dba Xtressé at 3 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 8 inclusion and 11 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: under way, not looking for participants, 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 3 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?
Increase in hair density assessed by Canfield HairMetrix® Phototrichogram Analysis (time frame: From enrollment to end of treatment at 4 months). The study lists 3 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; AzTrials last refreshed its copy on 7 Nov 2026.