Androgenetic AlopeciaNCT07919782
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
A study testing Xtressé Hair Growth Gummies in people with Androgenetic Alopecia, run by Restore Biologics Holdings, Inc. dba Xtressé at 1 site in United States.
Trial summary
The goal of this study is to determine how much Xtresse' gummy taken daily changes hair density in women with self-perceived thinning hair compared with placebo. Thirty-patients will be randomly assigned to receive either Xtresse' active gummy or placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Xtressé Hair Growth Gummies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2026to Nov 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
- Self-perceived thinning hair, confirmed by the investigator as Ludwig I or II
- Fitzpatrick skin types I to IV
- Stable thinning for at least 6 months
- No use of other hair loss treatment during participation. Stopped prior -treatments 3-6 months before participation.
- Willing to keep hair, length, color, and style comparable through Day 180.
- Willing to use contraception through day 180 if or childbearing potential.
- Able to attend all in-person study visits
Who cannot join
- Scalp disease that is clinically significant, involves the target area, or would interfere with assessment.
- Alopecia areata, active telogen effluvium, or other non-androgenetic hair loss.
- Prior hair transplant.
- Pregnant, breastfeeding, planning pregnancy during the study, or gave birth within the past 12 months.
- Hormone therapy started or changed within 3 months before Day 0.
- GLP-1 receptor agonist use, unless the dose has been stable and body weight has changed by no more than 5% for at least 6 months.
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- Weight change of more than 10% within 6 months before Day 0.
- Oral isotretinoin within 6 months before Day 0.
- Major illness, surgery, or other recognized shedding trigger within 6 months before Day 0.
- Bleeding or clotting disorder, or anticoagulant or antiplatelet therapy other than aspirin at 81 mg or less daily.
- Active liver disease, or poorly controlled diabetes, hypertension, or thyroid disease.
- Active malignancy or systemic immunosuppressant use.
- Known allergy to any ingredient in the active or placebo gummy.
- Unwilling to stop other supplements containing ashwagandha, turmeric, saw palmetto, or high-dose vitamins and minerals during the study.
- Participation in another clinical study within 30 days before Day 0.
- Any other condition the investigator judges would put the subject at risk or compromise the data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kindred Hair and Skin Center
Marriottsville, Maryland, 21104
Chesahna Kindred, MD
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Xtressé Hair Growth Gummy in Women With Self-Perceived Thinning Hair
The goal of this study is to determine how much Xtresse' gummy taken daily changes hair density in women with self-perceived thinning hair compared with placebo. Thirty-patients will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given.
The mains aims of this trial are:
Read more
- To confirm using photographic analysis , changes in terminal hair density.
- To confirm using photographic analysis, changes in total hair density and hair shaft size.
- To gauge patient satisfaction with hair changes and application process.
Participants who qualify will complete 3 in-person visits. Participants will be given a 90-day supply of the gummies at visit 1 (after voluntary consent is given) and visit 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 an adult female between 18 to 65 years of age with Ludwig I or II hair loss pattern.
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
- Androgenetic Alopecia
- Being tested
- Xtressé Hair Growth Gummies, Placebo Comparator
- Keywords
- 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. 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 15 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 | 15 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
Secondary outcomes (2)
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
Participant self-assessment of hair improvements collected via questionnaire
Observations and changes in hair loss graded on scale of -3 to 3 with -3 as Greatly Decreased, 0 as no change and 3 as Greatly Increased. Observations are based on self-assessments completed at baseline, Day 90, and Day 180.
Measured: From enrollment to the end of study 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 posted5 Nov 2026
- Study start16 Nov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionNov 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT07919782
- Sponsor's protocol ID
- RBH-2026-002
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Xtressé Hair Growth Gummy in Women With Self-Perceived Thinning Hair
- ClinicalTrials.gov ID
- NCT07919782
- Acronym / sponsor ID
- RBH-2026-002
- Conditions
- Androgenetic Alopecia
- Keywords
- thinning hair, Alopecia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Restore Biologics Holdings, Inc. dba XtresséIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 5 Nov 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 how much Xtresse' gummy taken daily changes hair density in women with self-perceived thinning hair compared with placebo. Thirty-patients will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given.
The mains aims of this trial are:
- To confirm using photographic analysis , changes in terminal hair density.
- To confirm using photographic analysis, changes in total hair density and hair shaft size.
- To gauge patient satisfaction with hair changes and application process.
Participants who qualify will complete 3 in-person visits. Participants will be given a 90-day supply of the gummies at visit 1 (after voluntary consent is given) and visit 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 an adult female between 18 to 65 years of age with Ludwig I or II hair loss pattern.
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, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xtressé Nutraceutical Supplement Active | Experimental | Other: Xtressé Hair Growth GummiesXtressé Nutraceutical Supplement 15 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 Comparator15 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
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-perceived thinning hair, confirmed by the investigator as Ludwig I or II
- Fitzpatrick skin types I to IV
- Stable thinning for at least 6 months
- No use of other hair loss treatment during participation. Stopped prior -treatments 3-6 months before participation.
- Willing to keep hair, length, color, and style comparable through Day 180.
Key exclusion criteria (16 listed)
- Scalp disease that is clinically significant, involves the target area, or would interfere with assessment.
- Alopecia areata, active telogen effluvium, or other non-androgenetic hair loss.
- Prior hair transplant.
- Pregnant, breastfeeding, planning pregnancy during the study, or gave birth within the past 12 months.
- Hormone therapy started or changed within 3 months before Day 0.
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.
2 secondary outcomes
Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis
Time frame: From enrollment to the end of treatment at 6 months
Participant self-assessment of hair improvements collected via questionnaire
Time frame: From enrollment to the end of study 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 5 Nov 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
1 site 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 Androgenetic Alopecia, run by Restore Biologics Holdings, Inc. dba Xtressé at 1 site 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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 5 Nov 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 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?
Contact Chesahna Kindred, MD (443-424-7754, research@kindredhairandskin.com), or a site near the patient. 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). 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 5 Nov 2026.