Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia

Part of paid clinical trials in Maitland, Florida.

Sponsor
Restore Biologics Holdings, Inc. dba Xtressé
Study ID
NCT07637071
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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. 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 in-person visits. Participants will be given a 90-day supply of the gummies at visits 1 (after voluntary consent is given) 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.

Key Dates

First listed
Jun 9, 2026
Start date
Sep 29, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Xtressé Nutraceutical Supplement Active
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis [ Time Frame: From enrollment to the end of treatment at 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Advanced Dermatology & Cosmetic SurgeryMaitlandFlorida32751
Dr. Priya Pohani
Matt Leavitt, DO (PRINCIPAL_INVESTIGATOR)
Advanced Dermatology & Cosmetic SurgeryPort OrangeFlorida32127
Kiya Arbogast
386-322-8310
Charles Dunn, MD (PRINCIPAL_INVESTIGATOR)

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