Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair

NCT07919782 · tracked via the Priya Life Science USA tracker

Sponsor

Restore Biologics Holdings, Inc. dba Xtressé

Phase

Not applicable

Started

2026-11-16

Last updated

2026-11-05

Condition(s) studied

Androgenetic Alopecia

Investigational drug(s) / intervention(s)

Xtressé Hair Growth GummiesPlacebo Comparator

Xtressé 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. The dosage is 2 gummies taken once per day.

Placebo Comparator: 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 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. Neither staff not participant will know which treatment is given.

The mains aims of this trial are:

1. To confirm using photographic analysis , changes in terminal hair density.
2. To confirm using photographic analysis, changes in total hair density and hair shaft size.
3. 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Kindred Hair and Skin Center	Marriottsville	Maryland

More Restore Biologics Holdings, Inc. dba Xtressé trials in the USA

Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair Enrolling by invitation

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

Study to Evaluate Xtresse Serum in Individuals With Thinning Hair Active, not recruiting

Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia Enrolling by invitation

XVIE to Treat Androgenetic Alopecia (AGA) Starting soon

Other trials for the same condition

Safety and Efficacy of VDPHL01 in Males and Females With AGA Active, not recruiting

Safety and Efficacy of VDPHL01 in Females With Androgenetic Alopecia (AGA) Active, not recruiting

Efficacy and Safety of VDPHL01 in Males With AGA Active, not recruiting

XVIE to Treat Androgenetic Alopecia (AGA) Starting soon

Phase 2/3 Efficacy and Safety of PP405 in Adult Males Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07919782 on ClinicalTrials.gov ↗ ← All trials in the USA