An interventional study of Xtressé Hair Growth Gummies and Placebo Comparator in Androgenic Alopecia, Hair Loss/Baldness and Hair Thinning, sponsored by Restore Biologics Holdings, Inc. dba Xtressé. Enrolling by invitation at 2 sites in United States. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Restore Biologics Holdings, Inc. dba Xtressé · Not applicable, Interventional, and Treatment
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:
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.
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 active or placebo 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.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's planned enrollment of 48 is close to the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →Restore Biologics Holdings, Inc. dba Xtressé is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 6 months
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
Time frame: From first treatment until the end of treatment at 6 months
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.
Time frame: From enrollment to the end of study at 6 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Restore Biologics Holdings, Inc. dba Xtressé