NCT07637071

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 men with androgenic alopecia. 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jun 2026Mar 2027

First Submitted

Initial submission to the registry

June 4, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

June 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 4, 2026

Last Update Submit

June 8, 2026

Conditions

Androgenic AlopeciaHair ThinningHair Loss/Baldness

Outcome Measures

Primary Outcomes (3)

  • 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 6 months of taking Xtressé™ Supplements. Measurements of density as measured hair per cm².

    From enrollment to the end of treatment at 6 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 6 months of taking Xtressé™ Supplements. Measurements of follicular unit vellus/terminal ratio.

    From enrollment to the end of treatment at 6 months

  • Hair Density Changes measured by SOCAi

    Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes.

    From enrollment to the end of treatment at 6 months

Secondary Outcomes (1)

  • Incidence of Adverse Events associated with Treatment

    From first treatment until the end of treatment at 6 months

Other Outcomes (1)

  • Participant self-assessment of hair improvements collected via questionnaire

    From enrollment to the end of study at 6 months

Study Arms (1)

Xtressé Nutraceutical Supplement Active

EXPERIMENTAL

Xtressé Nutraceutical Supplement Participants will receive a 90 day supply of the gummy supplement 2 times during the study. Participants will take supplement daily and notate usage in log.

Other: Xtressé Hair Growth Gummies

Interventions

Xtressé Hair Growth GummiesOTHER

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.

Xtressé Nutraceutical Supplement Active

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale sex at birth
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males aged 18-65
  • Norwood III to IV, vertex focused
  • Fitzpatrick skin type I to VI
  • Ability and willingness to comply with study protocol

You may not qualify if:

  • Change in other hair treatments in 3 months prior to study enrollment.
  • Known uncontrolled health conditions.
  • History of hair or scalp disorders that could interfere with study results.
  • History of metabolic syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Advanced Dermatology & Cosmetic Surgery

Maitland, Florida, 32751, United States

Location

Advanced Dermatology & Cosmetic Surgery

Port Orange, Florida, 32127, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Melissa Y Rayner, MS

    Restore Biologics Holdings, Inc. dba Xtressé

    STUDY DIRECTOR

Central Study Contacts

Dr. Matt Leavitt, DO

CONTACT

321-594-6851matt@xtresse.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label study evaluating safety and efficacy
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 9, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)