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

NCT07224555 | Enrolling By Invitation

• 1 other identifier: XTS-2025-001
• Study Type: interventional
• Target: 60
• 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 using an active gummy treatment in women with self-perceived 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 intake of Xtressé

Conditions

Hair Thinning

Keywords

hair loss; thin hair; thinning hair; Alopecia

Outcome Measures

Primary Outcomes (3)

• 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.

  From enrollment to the end of the study at 4 months

• 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.

  From enrollment to the end of treatment at 4 months

• 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.

  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)

• Participant self-assessment of hair improvements collected via questionnaire

  From enrollment to the end of study at 4 months

Study Arms (1)

Xtressé Nutraceutical Supplement Active

EXPERIMENTAL

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

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.

Xtressé Nutraceutical Supplement Active

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female sex at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 contraception throughout the study if of childbearing potential.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Restore Biologics Holdings, Inc. dba Xtressé: lead

Study Sites (4)

Advanced Dermatology & Cosmetic Surgery

Maitland, Florida, 32751, United States

Location

Hair Medicine Institute

Alpharetta, Georgia, 30005, United States

Location

Kindred Hair and Skin

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 Y Rayner, MS

  Restore Biologics Holdings, Inc. dba Xtressé

  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

Model Details: Open label study evaluating safety and efficacy

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: November 4, 2025
• Study Start: March 27, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)