Study to Evaluate Xtresse Serum in Individuals With Thinning Hair

NCT07228156 | Enrolling By Invitation

• 1 other identifier: XTRS-SERUM-2025-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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. 1.To confirm using photographic analysis, changes in the quality, volume, and thickness of hair.
2. 2.To gauge patient satisfaction with hair changes and application process.
3. 3.Monitor and report any adverse events associated with the daily usage of Xtressé serum.

Conditions

Thin Hair; Hair Loss; Alopecia; Thinning Hair

Keywords

Xtresse; serum

Outcome Measures

Primary Outcomes (3)

• Increase in hair density assessed by Canfield HairMetrix® Phototrichogram Analysis

  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.

  From enrollment to end of treatment at 4 months

• Hair Density changes measured by SOCAi

  Images will be captures using the SOCAI system at baseline and Days, 30, 60, 90, and 120 to evaluate hair density changes.

  From enrollment to the end of the study at 4 months

• 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 applying Xtressé™ Serum. Measurements of follicular unit vellus/terminal ratio.

  From enrollment to the end of treatment at 4 months

Secondary Outcomes (1)

• Incidence of Adverse Events associated with treatment

  From first treatment until the end of treatment at 4 months

Other Outcomes (1)

• Patient self-assessment of hair improvements collected via questionnaire

  From enrollment to the end of study at 4 months

Study Arms (1)

Single Group

EXPERIMENTAL

Xtresse Concentrate Serum Participants will receive 4-month supply of serum. They will apply serum to their scalp daily and notate usage log.

Other: Xtresse Serum

Interventions

Xtresse Serum OTHER

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.

Single Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Restore Biologics Holdings, Inc. dba Xtressé: lead

Study Sites (4)

Advanced Dermatology & Cosmetic Surgery

Maitland, Florida, 32751, United States

Location

Research Institute Southeast

West Palm Beach, Florida, 33401, United States

Location

Kindred Hair and Skin Center

Marriottsville, Maryland, 21104, United States

Location

Root Hair Institute

Bellevue, Washington, 98004, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa Rayner, MS

  Restore Biologics Holdings, Inc dba Xtresse

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 14, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)