XVIE to Treat Androgenetic Alopecia (AGA) (NCT07482423)
A Phase I/II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Potential Efficacy of XVIE Injected Intradermally in Patients With Androgenetic Alopecia
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Advanced Dermatology and Cosmetic Surgery — Orlando, Florida
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Advanced Dermatology and Cosmetic Surgery — Orlando, Florida
- Kindred Hair & Skin Center — Marriottsville, Maryland
📞 Contact the Study Coordinator
Phone: (855) 284-8266
Email: trill@xtresse.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Androgenetic Alopecia
- Safety and Efficacy of VDPHL01 in Males With AGA — Birmingham, Alabama
- Safety and Efficacy of VDPHL01 in Males and Females With AGA — San Diego, California
- Use of Botulinum Toxin in the Treatment of Androgenic Alopecia — Edina, Minnesota
- Efficacy and Safety of VDPHL01 in Males With AGA — Birmingham, Alabama
Explore by condition: All Androgenetic Alopecia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.