ClinicalTrials.gg
Enrolling by invitationNCT07224555Updated Jun 8, 2026

Study Evaluating Xtressé Gummy Supplement in Women With Self-Perceived Thinning Hair

An interventional study of Xtressé Hair Growth Gummies in Hair Thinning, sponsored by Restore Biologics Holdings, Inc. dba Xtressé. Enrolling by invitation at 4 sites in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Restore Biologics Holdings, Inc. dba Xtressé · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2025, registered Oct 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study 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. To gauge patient satisfaction with hair changes and application process.
  3. 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.

02

Conditions studied

  • Hair Thinning

Browse trials for

Keywords

  • hair loss
  • thin hair
  • thinning hair
  • Alopecia
03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Restore Biologics Holdings, Inc. dba Xtressé is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 throughout the study if of .

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Xtressé Nutraceutical Supplement Active

    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.

    Other: Xtressé Hair Growth Gummies

Interventions

  • OtherXtressé Hair Growth Gummies

    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.

06

What researchers measure

Primary 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.

    Time frame: From enrollment to the end of the study at 4 months

  2. 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.

    Time frame: From enrollment to the end of treatment at 4 months

  3. 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.

    Time frame: 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

    Time frame: From first treatment until the end of treatment at 4 months

Other outcomes

  1. Participant self-assessment of hair improvements collected via questionnaire

    Observations and changes noted in hair loss graded on scale of 0 to 4 with 0 as no change and 4 as a very severe outcome. Observations and changes noted in quality of life based on hair loss, with outcomes graded between extremely effected to not at all. Observations are based on self-assessments completed at baseline and Day 120.

    Time frame: From enrollment to the end of study at 4 months

07

Study locations

4 sites
  • Advanced Dermatology & Cosmetic Surgery
    Maitland, Florida 32751, United States
  • Hair Medicine Institute
    Alpharetta, Georgia 30005, United States
  • Kindred Hair and Skin
    Marriottsville, Maryland 21104, United States
  • Root Hair Institute
    Bellevue, Washington 98004, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Dec 2026, 21 months after the start.

Of 61 industry-sponsored interventional studies with no phase under Alopecia, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 21 months is above that.

Counting every sponsor, half of 146 studies reached it within 12 months; a quarter within 6 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2025
First posted
Nov 4, 2025
StartActual
Mar 27, 2025
Primary completionEst.
Dec 2026
CompletionEst.
Mar 2027
Last update
Jun 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07224555
Lead sponsor
Restore Biologics Holdings, Inc. dba Xtressé
Responsible party
Sponsor
First posted
Nov 4, 2025
Start date
Mar 27, 2025
Primary completion
Dec 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jun 8, 2026

Study contacts

Melissa Y Rayner, MS
study director · Restore Biologics Holdings, Inc. dba Xtressé

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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