Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia

NCT07637071 | Not Yet Recruiting

• 1 other identifier: XTSM-2026-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to determine if Xtresse' gummy is safe and may help regrow hair in men with androgenic alopecia (common pattern hair loss). Forty-eight participants will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given. 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

Androgenic Alopecia; Hair Thinning; Hair 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 (2)

Xtressé Nutraceutical Supplement Active

EXPERIMENTAL

Xtressé Nutraceutical Supplement 32 participants will be randomized to this group and 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

Placebo

PLACEBO COMPARATOR

16 individuals will be randomized to this group and 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.

Dietary Supplement: Placebo Comparator

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. The dosage is 2 gummies taken once per day.

Xtressé Nutraceutical Supplement Active

Placebo Comparator DIETARY_SUPPLEMENT

The placebo supplement will contain no active ingredients. Participants will receive 3 month supply 2 times during the study. Participants will take 2 supplements daily.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Male sex at birth
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Restore Biologics Holdings, Inc. dba Xtressé: lead

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)

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

Central Study Contacts

Dr. Matt Leavitt, DO

CONTACT

321-594-6851; matt@xtresse.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label study evaluating safety and efficacy

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: September 29, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)