An interventional study of XVIE in Hair Thinning, sponsored by Restore Biologics Holdings, Inc. dba Xtressé. Enrolling by invitation at 2 sites in United States. Open to female participants aged 28 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Restore Biologics Holdings, Inc. dba Xtressé · Not applicable, Interventional, and Treatment
The goal of this study is to determine how safe and effective it is to improve hair growth using XVIE solution applied on the scalp of women with self-perceived thinning hair.
The main aims of this trial are:
Participants who qualify will complete 5 to 6 visits after voluntary consent has been given. Participant's scalp will be numbed and the XVIE solution will be applied by microneedling. Photographs will be taken at each visit to measure changes in hair volume, thickness, and growth. Every participant will receive active treatment twice over the 4 month period.
XVIE is a proprietary, additive-free Human amniotic fluid (hAF) based therapy, containing a diverse array of bioactive molecules including growth factors, cytokines, hyaluronic acid, extracellular matrix proteins, and extracellular vesicles including exosomes. Extensive research have shown the ability of Xvie components to support cellular proliferation, angiogenesis, immune regulation, and matrix remodeling which has the potential to reverse underlying cause of hair loss.
In the study, participants will be asked to complete the following:
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 15 is below 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
XVIE is proprietary, additive-free human amniotic fluid derived product that contains an diverse array of bioreactive molecules including growth factors, cytokines, ECM proteins, exosomes, and hyaluronic acid.
Other: XVIE
Acellular Allogenic Human Amniotic Fluid (hAF)
Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis
Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after multiple treatments with XVIE
Time frame: From enrollment to the end of treatment at 4 months
Incidence of Adverse Events associated with Treatment
Collect and quantify the incidence of treatment-related adverse events and treatment-related serious adverse events that occur during the trial within 30 days of microneedling treatment.
Time frame: From first treatment until the end of treatment at 4 months.
Hair Density Changes measured by SOCAi
Images will be captured using the the SOCAi system at baseline and Days 30, 60, 90, and 120, to evaluate hair density changes.
Time frame: From enrollment to the end of the study at 4 months
Participant self-assessment of hair improvements collected via questionnaires
Observations and changes noted in hair loss graded on scale of 0 to 4 with 0 as no change and 4 as a very severe outcome. Observations and changes noted in quality of life based on hair loss, with outcomes graded between extremely effected to not at all. Observations are based on self-assessments completed at baseline and Day 120.
Time frame: From enrollment to the end of study at 4 months
Investigator assessment of changes in hair quality
Changes noted in hair quality graded on a scale of -3 to +3, with -3 as decreased/significantly worsened, 0 indicates no change, and +3 as increased/significantly improved
Time frame: From baseline to the end of the study at 4 months
Plan to share: No
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Restore Biologics Holdings, Inc. dba Xtressé