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

The registered record

Accession number

NCT07221773

Lead sponsor

Restore Biologics Holdings, Inc. dba Xtressé (industry)

Registered condition naming hair loss

Hair Thinning

Official title

Pilot Study to Evaluate the Efficacy and Safety of Xvie (Human Amniotic Fluid Derived Nanoparticle Solution) Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair

Interventions

• OtherXVIE

Names and types as registered. The sponsors' free-text descriptions of these interventions are not reproduced: they are written by the party with an interest in the result, and reprinting them inside this site's layout would lend them this site's voice.

Design

Study type

interventional

Phase

Not applicable

Allocation

na

Masking

none

Primary purpose

treatment

Enrolment

15 participants (estimated)

Sites

2 locations in United States

What it measures

1. Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis

   Time frame: From enrollment to the end of treatment at 4 months

2. Incidence of Adverse Events associated with Treatment

   Time frame: From first treatment until the end of treatment at 4 months.

Primary outcome measures only, as registered. What a trial chose to measure, and when, is the most informative thing about it that is knowable before it reports — a hair-count endpoint at 24 weeks and a patient-satisfaction endpoint at 12 weeks are not the same study.

Who can take part

Sex

female

Age

28 Years to 65 Years

Healthy volunteers

not accepted

A summary of three registered fields, not the eligibility criteria. The full inclusion and exclusion criteria, the recruiting sites and the study contacts are on the registry record, which is the only place they are maintained. This site has no relationship with this trial and cannot refer anyone to it.

Registered dates

Study start

29 September 2025 (actual)

Primary completion

December 2026 (estimated)

Study completion

February 2027 (estimated)

First posted

28 October 2025 (actual)

Last update posted

8 June 2026 (actual)

"Estimated" and "actual" are the registry's own labels: an estimated date is a plan, and plans move. A date is printed at the precision it was registered at: a primary completion registered as 2026-12 is a month, and rendering it as 1 December 2026 would invent a day the sponsor did not register.

Results

This trial has not reported results. ClinicalTrials.gov holds no results record for it. That is the ordinary state of a trial that is running or about to run, and it means there is nothing here to tell you about whether the intervention works — including nothing negative. If this page implied otherwise it would be wrong.

On this site

Guides covering the condition this trial is registered for. They are about published evidence; this page is about a registration, and the two do not overlap.

Diffuse Thinning vs. Pattern Baldness: How to Tell the Difference (2026 Guide)How to Tell If You're Going Bald: Early Signs & Self-Assessment Guide (2026)

Where this came from

Read from the ClinicalTrials.gov API on 6 September 2026 and rebuilt into this page without alteration. ClinicalTrials.gov is a service of the U.S. National Library of Medicine and is the authority on this record; where this page and the registry disagree, the registry is right. This page is not affiliated with or endorsed by NLM or NIH, or with the sponsor of this trial.

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