Hair ThinningNCT07224555
Study Evaluating Xtressé Gummy Supplement in Women With Self-Perceived Thinning Hair
A study testing Xtressé Hair Growth Gummies in people with Hair Thinning, run by Restore Biologics Holdings, Inc. dba Xtressé at 4 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 an active gummy treatment in 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 18 to 65 years, women only
- Conditions the study is for
- Hair Thinning
- What is being tested?
- Xtressé Hair Growth Gummies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Mar 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-65 years with self-perceived thinning hair (confirmed by an investigator).
- 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 metabolic syndrome.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Hair Medicine Institute
Alpharetta, Georgia, 30005
Root Hair Institute
Bellevue, Washington, 98004
Advanced Dermatology & Cosmetic Surgery
Maitland, Florida, 32751
Kindred Hair and Skin
Marriottsville, Maryland, 21104
About this study
Official title: Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement 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 an active gummy treatment in 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.
- Monitor and report any adverse events associated with the daily intake of Xtressé
Participants who qualify will complete 5 visits after voluntary consent has been given. Participants will be given a 30-day supply of the gummies at each visit over a 4-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.
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
- Take gummy treatment daily and complete a treatment diary
- 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 a female adult between 28 to 65 years of age
- 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 treatments 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
- Hair Thinning
- Being tested
- Xtressé Hair Growth Gummies
- Keywords
- hair loss, thin hair, thinning hair, Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xtressé Hair Growth GummiesOther
The nutraceutical supplement 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 |
|---|---|---|
| Xtressé Nutraceutical Supplement Active | Experimental | Other: Xtressé Nutraceutical Supplement Participants will receive a 30 day supply of gummy supplement 4 times during the study. Participants will take supplement daily and notate usage in log. Receives: Other: Xtressé Hair Growth Gummies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after taking Xtressé™ Supplements. Measurements of density as measured hair per cm².
Measured: From enrollment to the end of treatment at 4 months
Within-subject 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 taking Xtressé™ Supplements. 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 intake of supplement
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 posted4 Nov 2025
- Study start27 Mar 2025
- Primary completionDec 2026 (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 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
- 60 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 Holdings, Inc. dba Xtressé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224555
- Sponsor's protocol ID
- XTS-2025-001
- Status last verified
- Nov 2025
- First submitted
- 29 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 Xtressé™ Gummy-Based Nutraceutical Supplement in Women With Self-Perceived Thinning Hair
- ClinicalTrials.gov ID
- NCT07224555
- Acronym / sponsor ID
- XTS-2025-001
- Conditions
- Hair Thinning
- Keywords
- hair loss, thin hair, thinning hair, Alopecia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Restore Biologics Holdings, Inc. dba XtresséIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 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 using an active gummy treatment in 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.
- Monitor and report any adverse events associated with the daily intake of Xtressé
Participants who qualify will complete 5 visits after voluntary consent has been given. Participants will be given a 30-day supply of the gummies at each visit over a 4-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth.
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
- Take gummy treatment daily and complete a treatment diary
- 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 a female adult between 28 to 65 years of age
- 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 treatments 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
- Model description
- Open label study evaluating safety and efficacy
| Arm | Type | Receives |
|---|---|---|
| Xtressé Nutraceutical Supplement Active | Experimental | Other: Xtressé Hair Growth GummiesOther: Xtressé Nutraceutical Supplement Participants will receive a 30 day supply of gummy supplement 4 times during the study. Participants will take supplement daily and notate usage in log. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18-65 years with self-perceived thinning hair (confirmed by an investigator).
- 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 (5 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 metabolic syndrome.
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 |
|---|---|---|
| Xtressé Hair Growth GummiesThe nutraceutical supplement is powered by proprietary X-3 BioActive Blend and contains plant based extracts and regenerative compounds not commonly found in existing hair supplements. | Other | Xtressé Nutraceutical Supplement Active |
Primary outcome
Hair Density Changes measured by SOCAi
Time frame: From enrollment to the end of the study at 4 months
Images will be captured using the the SOCAi system at baseline and Days 30, 60, 90, and 120, to evaluate hair density changes.
Within-subject increase in hair density 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 taking Xtressé™ Supplements. Measurements of density as measured hair per cm².
Within-subject 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 taking Xtressé™ Supplements. 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
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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 Holdings, Inc. dba Xtressé
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xtressé Hair Growth Gummies in people with Hair Thinning, run by Restore Biologics Holdings, Inc. dba Xtressé at 4 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 4 inclusion and 5 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 4 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?
Hair Density Changes measured by SOCAi (time frame: From enrollment to the end of the study 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.