Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia

Condition(s) studied

Investigational drug(s) / intervention(s)

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. The dosage is 2 gummies taken once per day.

Placebo Comparator: 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 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. 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.

Eligibility

Primary outcome measure(s)

• Within-subject increase in hair density assessed via Canfield HairMetrix® Phototrichogram Analysis — From enrollment to the end of treatment at 6 months
  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.
• Within-subject increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis — From enrollment to the end of treatment at 6 months
  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.
• Hair Density Changes measured by SOCAi — From enrollment to the end of treatment at 6 months
  Images will be captured using the the SOCAi system at baseline and Days 90, and 180, to evaluate hair density changes.

Trial sites (2)