What this study is
Simplified from ClinicalTrials.govTesting a daily hair growth gummy supplement (Xtressé) to see whether it changes hair density compared with a placebo (a gummy with no active ingredient), in women ages 18 to 65 who feel their hair is thinning.
Read the original summary from ClinicalTrials.gov
The goal of this study is to determine how much Xtresse' gummy taken daily changes hair density in women with self-perceived thinning hair compared with placebo. Thirty-patients will be randomly assigned to receive either Xtresse' active gummy or placebo. Neither staff not participant will know which treatment is given.
The mains aims of this trial are:
1. To confirm using photographic analysis , changes in terminal hair density. 2. To confirm using photographic analysis, changes in total hair density and hair shaft size. 3. To gauge patient satisfaction with hair changes and application process.
Participants who qualify will complete 3 in-person visits. Participants will be given a 90-day supply of the gummies at visit 1 (after voluntary consent is given) and visit 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.
What's being tested
- Xtressé Hair Growth Gummies
Intervention · 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
Intervention · 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
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Xtressé Hair Growth Gummy in Women With Self-Perceived Thinning Hair
- Sponsor
- Restore Biologics Holdings, Inc. dba Xtressé
- Conditions
- Androgenetic Alopecia
- Enrolling
- 30 people
- Starts
- 2026-11-16
- Est. completion
- 2027-11
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Self-perceived thinning hair, confirmed by the investigator as Ludwig I or II
- Fitzpatrick skin types I to IV
- Stable thinning for at least 6 months
- No use of other hair loss treatment during participation. Stopped prior -treatments 3-6 months before participation.
- Willing to keep hair, length, color, and style comparable through Day 180.
- Willing to use contraception through day 180 if or childbearing potential.
- Able to attend all in-person study visits
You can't join if
- Scalp disease that is clinically significant, involves the target area, or would interfere with assessment.
- Alopecia areata, active telogen effluvium, or other non-androgenetic hair loss.
- Prior hair transplant.
- Pregnant, breastfeeding, planning pregnancy during the study, or gave birth within the past 12 months.
- Hormone therapy started or changed within 3 months before Day 0.
- GLP-1 receptor agonist use, unless the dose has been stable and body weight has changed by no more than 5% for at least 6 months.
- Weight change of more than 10% within 6 months before Day 0.
- Oral isotretinoin within 6 months before Day 0.
- Major illness, surgery, or other recognized shedding trigger within 6 months before Day 0.
- Bleeding or clotting disorder, or anticoagulant or antiplatelet therapy other than aspirin at 81 mg or less daily.
- Active liver disease, or poorly controlled diabetes, hypertension, or thyroid disease.
- Active malignancy or systemic immunosuppressant use.
- Known allergy to any ingredient in the active or placebo gummy.
- Unwilling to stop other supplements containing ashwagandha, turmeric, saw palmetto, or high-dose vitamins and minerals during the study.
- Participation in another clinical study within 30 days before Day 0.
- Any other condition the investigator judges would put the subject at risk or compromise the data.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openKindred Hair and Skin Center
Marriottsville, Maryland, United States
- Chesahna Kindred, MD · Principal investigator
Study team
Sponsor
Restore Biologics Holdings, Inc. dba Xtressé
Study ID RBH-2026-002
Study director
Melissa Y Rayner, MS
Restore Biologics Holding, Inc dba Xtressé
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.