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Clinical Trials in the USA / NCT07228156
Active, not recruiting Not applicable

Study to Evaluate Xtresse Serum in Individuals With Thinning Hair

NCT07228156 · tracked via the Priya Life Science USA tracker
Sponsor
Restore Biologics Holdings, Inc. dba Xtressé
Phase
Not applicable
Started
2025-12-17
Last updated
2026-06-08

Condition(s) studied

Thin HairHair LossAlopeciaThinning Hair

Investigational drug(s) / intervention(s)

Xtresse Serum

Xtresse Serum: The concentrate serum is powered by proprietary X-3 BioActive Blend and contains plant-based extracts and regenerative compounds not commonly found in existing hair supplements.

Study summary

The goal of this study is to determine how safe and effective it is to improve hair growth by applying a serum daily on the scalp of men and women with 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 usage of Xtressé serum.

Participants who qualify will complete 7 visits after voluntary consent has been given. Participants will be given 9 bottles of serum to use during the study. The product will be applied daily over a 9-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth. Participants will complete a survey in the middle and at the end of the study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Women and Men Aged 18-65 years with self-perceived hair thinning (confirmed by an investigator). * Fitzpatrick skin Types I to IV * Ludwig Scale I or II or Norwood Scale 1 to 4 (mild to moderate thinning hair) * Agree to maintain their current diet, medication, exercise routines, hair shampooing, and color treatment frequency for the duration of the study. * Ability and willingness to comply with the study protocol including regular visits and product application. * Written informed consent obtained, including written consent to allow photographs to be used as part of the study data and documentation. * For females of childbearing potential, a negative pregnancy test at screening. * Commitment to using effective contraception throughout the study. Exclusion Criteria: * Pregnancy, nursing, planning to become pregnant. * Initiation of hormone therapy or changes in hormonal therapy within 6 months prior to enrollment and throughout the study. * Use of other medical hair loss treatments (e.g. Minoxidil, Dutasteride, Finasteride, laser or light therapy) within 3 months prior to the study and throughout the study. * Microneedling, PRP, or other physical treatment modality on the scalp within 6 months prior to the study and throughout the study. * Use of GLP-1 inhibitors (e.g. semaglutide) within 6 months prior to the study and throughout the study. * Known uncontrolled health conditions (poorly controlled diabetes, hypertension). * History of scalp disorders that could interfere with study results. * Known sensitivity to any of the ingredients in the study medication. * In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study. * Subject has any conditions, findings in history, physical exam, or laboratory assessments, which in the opinion of the investigator, would exclude the subject from continuing in this study. * Treatment with an experimental drug, biologic, or device within 12 weeks of the screening visit.

Primary outcome measure(s)

  • Increase in hair density assessed by Canfield HairMetrix® Phototrichogram Analysis — From enrollment to end of treatment at 4 months
    Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months of application of Xtressé™ serum. Measurements of density as measured hair per cm².
  • Hair Density changes measured by SOCAi — From enrollment to the end of the study at 4 months
    Images will be captures using the SOCAI system at baseline and Days, 30, 60, 90, and 120 to evaluate hair density changes.
  • Increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis — From enrollment to the end of treatment at 4 months
    Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after applying Xtressé™ Serum. Measurements of follicular unit vellus/terminal ratio.

Trial sites (3)

FacilityCityRegionStatus
Advanced Dermatology & Cosmetic Surgery Maitland Florida
Kindred Hair and Skin Center Marriottsville Maryland
Root Hair Institute Bellevue Washington

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
XVIE to Treat Androgenetic Alopecia (AGA) Starting soon
Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia Enrolling by invitation
Study Evaluating Xtressé Gummy Supplement in Women With Self-Perceived Thinning Hair Enrolling by invitation
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair Starting soon

Other trials for the same condition

Blood Specimen Collection For Laboratory Assay Research Recruiting
Autologous Hair Follicle Secretome for Androgenic Alopecia (Single Site) Recruiting
Efficacy and Safety of TargetCool + Benev Exosomes in Patients With Hair Thinning Active, not recruiting
A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata Recruiting
Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser 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 NCT07228156 on ClinicalTrials.gov ↗ ← All trials in the USA