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NCT07221773

Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair

Enrolling by Invitation
NAAges 28–65InterventionalTreatment
Restore Biologics Holdings, Inc. dba Xtressé
~15 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:XVIE

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis
Measured over From enrollment to the end of treatment at 4 months
+1 more outcome measured

Conditions

Hair Thinning

Explore related trials

AlopeciaFemale Pattern Hair Loss

Where it's being run

2 sites across 2 states
Florida1
Maryland1

Study leadership

  • Melissa Y Rayner, MS · STUDY_DIRECTOR · Restore Biologics Holding, Inc dba Xtressé

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Women aged 28-65 years with self-perceived thinning hair (confirmed by an investigator).
Ludwig Scale 1 to 2
Fitzpatrick skin types I to VI.
Ability and willingness to comply with the study protocol.
Commitment to using effective contraception throughout the study if of childbearing potential.

Exclusion

Pregnancy, nursing, or recent initiation of hormone therapy.
Change in other hair treatments within 3 months prior to the study.
Known uncontrolled health conditions (e.g., poorly controlled diabetes, hypertension).
History of hair or scalp disorders that could interfere with study results.
History of keloid formation or poor wound healing
History of bleeding and/or clotting disorders

What this trial measures

  • Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram AnalysisFrom enrollment to the end of treatment at 4 months

    Quantitative hair measurements calculated by analyzing the participants digital images from baseline to 4 months after multiple treatments with XVIE

  • Incidence of Adverse Events associated with TreatmentFrom first treatment until the end of treatment at 4 months.

    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.