This study tests whether XVIE, an investigational injectable product made from processed human amniotic fluid, is safe and may help regrow hair in adults with androgenetic alopecia (common pattern hair loss). XVIE contains growth factors and extracellular vesicles that may stimulate hair follicle activity. Thirty participants will be randomly assigned to receive either XVIE or a saline placebo injected into the scalp in two treatment sessions, 90 days apart. Neither participants nor study staff will know which treatment is being given. Participants will be followed for 6 months. The main goal is to evaluate safety. A secondary goal is to assess whether hair count, density, or coverage improves.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, aged 18 to 70 years (inclusive) at the time of informed consent
* Able to understand and voluntarily provide written informed consent
* Willing and able to comply with study procedures, including all scheduled visits and assessments
* In good general health as determined by the Investigator based on medical history and screening assessments
* Clinical diagnosis of androgenetic alopecia (AGA) with documented hair loss for at least 6 months prior to screening
* Stable pattern of hair loss (no rapid progression) for at least 6 months prior to screening
* Male subjects: Norwood-Hamilton Classification Stage III, IIIa, IIIv, IV, or IVa
* Female subjects: Ludwig Classification Stage I or II
* Normal thyroid function (TSH within normal limits) at screening, or stable on thyroid replacement therapy for at least 6 months
* Ferritin level within normal limits at screening, or documented adequate iron stores
* No clinically significant abnormalities on CBC with differential or comprehensive metabolic panel (CMP) at screening outside protocol-defined eligibility thresholds
* Female subjects of childbearing potential must have a negative urine pregnancy test at screening and agree to use an effective method of contraception throughout the study and for 30 days after the last treatment
* Female subjects who are postmenopausal (no menses for at least 12 months) or surgically sterile are not required to use contraception
Exclusion Criteria:
* Use of t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-emergent adverse events (TE-AEs) and treatment-emergent serious adverse events (TE-SAEs) as assessed by CTCAE v5.0
Timeframe: Baseline through Day 180
Trial details
NCT IDNCT07482423
SponsorRestore Biologics Holdings, Inc. dba Xtressé