Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia

Pilot Study to Evaluate the Efficacy and Safety of Xtressé™ Gummy-Based Nutraceutical Supplement in Men With Androgenic Alopecia

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. 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 intake of Xtressé

Participants who qualify will complete 3 visits after voluntary consent has been given. Participants will be given a 90-day supply of the gummies at visits 1 and 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Androgenic Alopecia; Hair Loss/Baldness; Hair Thinning
• Intervention / Treatment: Other: Xtressé Hair Growth Gummies

Detailed Description

In the study, participants will be asked to complete the following:

Provide basic personal information (including date of birth, gender, race and ethnicity) Provide their medical/ surgical history and perform a medical exam (including but not limited to symptom-directed physical exam, skin type, vital signs, height, weight) Follow study rules such as avoiding certain medications and treatments Provide information on any medications, treatments or reactions that started after the study began Take gummy treatment daily and complete a treatment diary Allow clinical assessments and documentation of the treatment, such as photography, hair density measurements, any reactions or side effects

To qualify for this trial, participants must:

Be a male adult between 18 to 65 years of age Have hair loss in vertex region. Give voluntary written consent Be willing to follow study instructions and complete study requirements, including maintaining current diet and hair care routine, not using non-approved lotions and creams on the treatments areas Allow photographs of the front and top area of the scalp Confirm they are not sensitive to any of the study treatment ingredients

All photographs of the treatment area collected during the study will be used as study data.

All participants have the right to refuse further participation in the study at any time.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Matt Leavitt, DO; Phone Number: 321-594-6851; Email: matt@xtresse.com

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Advanced Dermatology & Cosmetic Surgery
      • Principal Investigator: Matt Leavitt, DO
      • Contact: Dr. Priya Pohani; Email: DrPPohani@adcsclinics.com
    • Port Orange, Florida, United States, 32127
      • Advanced Dermatology & Cosmetic Surgery
      • Contact: Kiya Arbogast; Phone Number: 386-322-8310; Email: DrCDunn@adcsclinics.com
      • Principal Investigator: Charles Dunn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xtressé Nutraceutical Supplement Active; Xtressé Nutraceutical Supplement Participants will receive a 90 day supply of gummy supplement 2 times during the study. Participants will take supplement daily and notate usage in log.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events associated with Treatment	Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events associated with the daily intake of supplement	From first treatment until the end of treatment at 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant self-assessment of hair improvements collected via questionnaire	Observations and changes in hair loss graded on scale of 0 to 4 with 0 as no change and 4 as a very severe outcome. Observations are based on self-assessments completed at baseline and Day 180.	From enrollment to the end of study at 6 months

Collaborators and Investigators

• Sponsor: Restore Biologics Holdings, Inc. dba Xtressé
• Investigators: Study Director: Melissa Y Rayner, MS, Restore Biologics Holdings, Inc. dba Xtressé

Study record dates

Study Major Dates

• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Skin Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Alopecia
• Other Study ID Numbers: XTSM-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No