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

Sponsored by Restore Biologics Holdings, Inc. dba Xtressé

About this trial

Last updated 7 months ago

Study ID

XVIEP-2025-001

Status

Enrolling by invitation

Type

Interventional

Phase

N/A

Placebo

Accepting

28 to 65 Years

Female

Trial Timing

Started 8 months ago

What is this trial about?

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: 1. To confirm using photographic analysis, changes in the quality, volume, and thickness of hair. 2. To gauge patient satisfaction with hair changes and application process. 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.

What are the participation requirements?

Inclusion Criteria

* 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 Criteria

* 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