Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling… (NCT07221773) | Clinical Trial Compass
By InvitationNot Applicable
Pilot Study to Evaluate the Efficacy and Safety of Xvie Delivered Into the Scalp by Microneedling in Women With Self-perceived Thinning Hair
United States15 participantsStarted 2025-09-29
Plain-language summary
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.
Who can participate
Age range
28 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Within-subject increase in hair quality, volume, and thickness, assessed via Canfield HairMetrix® Phototrichogram Analysis
Timeframe: From enrollment to the end of treatment at 4 months
2
Incidence of Adverse Events associated with Treatment
Timeframe: From first treatment until the end of treatment at 4 months.
Trial details
NCT IDNCT07221773
SponsorRestore Biologics Holdings, Inc. dba Xtressé