Androgenic AlopeciaNCT07637071
Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
A study testing Xtressé Hair Growth Gummies in people with Androgenic Alopecia and Hair Loss/Baldness, run by Restore Biologics Holdings, Inc. dba Xtressé at 2 sites in United States.
Trial summary
The goal of this study is to determine if Xtresse' gummy is safe and may help regrow hair in men with androgenic alopecia (common pattern hair loss). Forty-eight participants will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Androgenic Alopecia, Hair Loss/Baldness, Hair Thinning
- What is being tested?
- Xtressé Hair Growth Gummies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Sep 2026to Sep 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged 18-65
- Norwood III to IV, vertex focused
- Fitzpatrick skin type I to VI
- Ability and willingness to comply with study protocol
Who cannot join
- Change in other hair treatments in 3 months prior to study enrollment.
- Known uncontrolled health conditions.
- History of hair or scalp disorders that could interfere with study results.
- History of metabolic syndrome.
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
Advanced Dermatology & Cosmetic Surgery
Port Orange, Florida, 32127
About this study
Official title: A Multi-center, Randomized, Double-Blind, Placebo- Controlled Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement in Men With Androgenic Alopecia
The goal of this study is to determine if Xtresse' gummy is safe and may help regrow hair in men with androgenic alopecia (common pattern hair loss). Forty-eight participants will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given.
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 3 in-person visits. Participants will be given a 90-day supply of the gummies at visits 1 (after voluntary consent is given) and 2 to cover the 6-month study 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) 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 active or placebo 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 male adult between 18 to 65 years of age Have hair loss in vertex region. 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 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
- Androgenic Alopecia, Hair Loss/Baldness, Hair Thinning
- Being tested
- Xtressé Hair Growth Gummies, Placebo Comparator
- 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. The dosage is 2 gummies taken once per day.
Placebo ComparatorDietary supplement
The placebo supplement will contain no active ingredients. Participants will receive 3 month supply 2 times during the study. Participants will take 2 supplements daily.
| Study group | Role | What they receive |
|---|---|---|
| Xtressé Nutraceutical Supplement Active | Experimental | Xtressé Nutraceutical Supplement 32 participants will be randomized to this group and receive a 90 day supply of the gummy supplement 2 times during the study. Participants will take supplement daily and notate usage in log. Receives: Other: Xtressé Hair Growth Gummies |
| Placebo | Placebo comparator | 16 individuals will be randomized to this group and will receive a 90 day supply of the gummy supplement 2 times during the study. Participants will take supplement daily and notate usage in log. Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 6 months of taking Xtressé™ Supplements. Measurements of density as measured hair per cm².
Measured: From enrollment to the end of treatment at 6 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 6 months of taking Xtressé™ Supplements. Measurements of follicular unit vellus/terminal ratio.
Measured: From enrollment to the end of treatment at 6 months
Hair Density Changes measured by SOCAi
Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes.
Measured: From enrollment to the end of treatment at 6 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 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start23 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label study evaluating safety and efficacy
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 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
- NCT07637071
- Sponsor's protocol ID
- XTSM-2026-001
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2026
- Last updated
- 27 Oct 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-Blind, Placebo- Controlled Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement in Men With Androgenic Alopecia
- ClinicalTrials.gov ID
- NCT07637071
- Acronym / sponsor ID
- XTSM-2026-001
- Conditions
- Androgenic Alopecia, Hair Loss/Baldness, Hair Thinning
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Restore Biologics Holdings, Inc. dba XtresséIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Jun 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.
The goal of this study is to determine if Xtresse' gummy is safe and may help regrow hair in men with androgenic alopecia (common pattern hair loss). Forty-eight participants will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given.
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 3 in-person visits. Participants will be given a 90-day supply of the gummies at visits 1 (after voluntary consent is given) and 2 to cover the 6-month study 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) 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 active or placebo 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 male adult between 18 to 65 years of age Have hair loss in vertex region. 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Open label study evaluating safety and efficacy
| Arm | Type | Receives |
|---|---|---|
| Xtressé Nutraceutical Supplement Active | Experimental | Other: Xtressé Hair Growth GummiesXtressé Nutraceutical Supplement 32 participants will be randomized to this group and receive a 90 day supply of the gummy supplement 2 times during the study. Participants will take supplement daily and notate usage in log. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Comparator16 individuals will be randomized to this group and will receive a 90 day supply of the gummy supplement 2 times during the study. Participants will take supplement daily and notate usage in log. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males aged 18-65
- Norwood III to IV, vertex focused
- Fitzpatrick skin type I to VI
- Ability and willingness to comply with study protocol
Key exclusion criteria (4 listed)
- Change in other hair treatments in 3 months prior to study enrollment.
- Known uncontrolled health conditions.
- 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. The dosage is 2 gummies taken once per day. | Other | Xtressé Nutraceutical Supplement Active |
| Placebo ComparatorThe placebo supplement will contain no active ingredients. Participants will receive 3 month supply 2 times during the study. Participants will take 2 supplements daily. | Dietary supplement | Placebo |
Primary outcome
Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis
Time frame: From enrollment to the end of treatment at 6 months
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 6 months of 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 6 months
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 6 months of taking Xtressé™ Supplements. Measurements of follicular unit vellus/terminal ratio.
Hair Density Changes measured by SOCAi
Time frame: From enrollment to the end of treatment at 6 months
Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes.
1 secondary outcome
Incidence of Adverse Events associated with Treatment
Time frame: From first treatment until the end of treatment at 6 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 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Androgenic Alopecia
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Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
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Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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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
2 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 Androgenic Alopecia and Hair Loss/Baldness, 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 4 inclusion and 4 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 27 Oct 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. Some participants in this study may receive a placebo. 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 density assessed via Canfield HairMetrix® Phototrichogram Analysis (time frame: From enrollment to the end of treatment at 6 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 27 Oct 2026.