Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair

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.

• Xtressé Hair Growth Gummies (Other): 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 Comparator (Dietary 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.

Primary outcomes

• Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis [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.

Secondary outcomes

• Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis [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.
• Participant self-assessment of hair improvements collected via questionnaire [From enrollment to the end of study at 6 months]: 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.

Other outcomes

• Follicle gene activity [From enrollment to the end of study at 6 months]: Measure gene activity in hair follicles plucked at Day 0, 90, and 180. Testing includes no DNA or genetic testing.
• Investigator assessment of changes in hair quality [From enrollment to the end of study at 6 months]: Changes noted in hair quality graded on a scale of -3 to +3, with -3 as decreased/significantly worsened, 0 indicates no change, and +3 as increased/significantly improved

Sex: Female, ages: 18 Years to 65 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

• Melissa Y Rayner, MS, Study director, Restore Biologics Holding, Inc dba Xtressé