XVIE for Alopecia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment, XVIE, to determine if it can safely and effectively boost hair growth in women experiencing thinning hair. The study will track changes in hair quality, volume, and thickness using photos and gather feedback on participants' satisfaction with the results and application process. Women who have noticed thinning hair and meet specific criteria can participate. Participants will receive the treatment, applied to their scalp with tiny needles, twice over four months. As an unphased trial, this study offers participants the opportunity to potentially benefit from a novel treatment while contributing to valuable research.
Do I need to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you've recently changed hair treatments, you may not be eligible.
What prior data suggests that the XVIE microneedling process is safe for improving hair growth?
Research shows that using the XVIE solution on the scalp is generally safe. Made from human amniotic fluid, this solution has been studied for its potential to boost hair growth. In earlier studies, researchers applied it with microneedling, a method involving tiny needle pricks, and found it to be safe with few side effects.
While the quality of data on microneedling can vary, some studies have shown it can aid hair growth without major side effects. Most participants in these studies did not experience serious problems. Although the safety of XVIE has been studied, further research could provide clearer results. However, current evidence suggests it is safe for use in hair growth treatments.12345Why are researchers excited about this trial?
Unlike standard treatments for alopecia, which often include topical minoxidil or oral finasteride, XVIE is a unique approach that uses a microneedling process to apply a human amniotic fluid-derived product directly to the scalp. This treatment is rich in bioreactive molecules like growth factors, cytokines, and hyaluronic acid, which are believed to promote hair growth by regenerating and repairing scalp tissues. Researchers are excited about XVIE because it leverages these advanced biological components to potentially offer a more effective and regenerative treatment option for hair loss.
What evidence suggests that XVIE might be an effective treatment for alopecia?
Research has shown that microneedling can aid hair growth. Studies have found it to be a safe and promising method for both men and women experiencing hair loss. This trial will evaluate the effectiveness of the XVIE microneedling process, which involves creating tiny holes in the scalp to enhance treatment efficacy. XVIE contains active ingredients, such as growth factors and proteins, that promote hair growth. While microneedling alone has shown potential, combining it with XVIE might further improve results.13467
Who Is on the Research Team?
Melissa Y Rayner, MS
Principal Investigator
Restore Biologics Holding, Inc dba Xtressé
Are You a Good Fit for This Trial?
This trial is for women experiencing self-perceived thinning hair who wish to improve their hair growth. Participants will need to attend 5 to 6 visits over a period of 4 months and are comfortable with having their scalp numbed for the microneedling procedure that applies XVIE solution.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the XVIE solution applied to the scalp by microneedling twice over a 4 month period
Follow-up
Participants are monitored for safety and effectiveness after treatment, including photographic documentation and self-assessments
What Are the Treatments Tested in This Trial?
Interventions
- XVIE
Find a Clinic Near You
Who Is Running the Clinical Trial?
Restore Biologics Holdings, Inc. dba Xtressé
Lead Sponsor