Active — Not RecruitingNot Applicable

Study to Evaluate Xtresse Serum in Individuals With Thinning Hair

United States40 participantsStarted 2025-12-17

Plain-language summary

The goal of this study is to determine how safe and effective it is to improve hair growth by applying a serum daily on the scalp of men and women with 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. 3. Monitor and report any adverse events associated with the daily usage of Xtressé serum. Participants who qualify will complete 7 visits after voluntary consent has been given. Participants will be given 9 bottles of serum to use during the study. The product will be applied daily over a 9-month period. Photographs and scalp analysis will be performed at each visit to measure changes in hair volume, thickness, and growth. Participants will complete a survey in the middle and at the end of the study.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

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 and Men Aged 18-65 years with self-perceived hair thinning (confirmed by an investigator). * Fitzpatrick skin Types I to IV * Ludwig Scale I or II or Norwood Scale 1 to 4 (mild to moderate thinning hair) * Agree to maintain their current diet, medication, exercise routines, hair shampooing, and color treatment frequency for the duration of the study. * Ability and willingness to comply with the study protocol including regular visits and product application. * Written informed consent obtained, including written consent to allow photographs to be used as part of the study data and documentation. * For females of childbearing potential, a negative pregnancy test at screening. * Commitment to using effective contraception throughout the study. Exclusion Criteria: * Pregnancy, nursing, planning to become pregnant. * Initiation of hormone therapy or changes in hormonal therapy within 6 months prior to enrollment and throughout the study. * Use of other medical hair loss treatments (e.g. Minoxidil, Dutasteride, Finasteride, laser or light therapy) within 3 months prior to the study and throughout the study. * Microneedling, PRP, or other physical treatment modality on the scalp within 6 months prior to the study and throughout the study. * Use of GLP-1 inhibitors (e.g. semaglutide) within 6 months prior to the study and throughout the study. * Known uncontrolled health conditions (poorly controlled diabetes, hypertension). * History of scalp disorder…

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

Increase in hair density assessed by Canfield HairMetrix® Phototrichogram Analysis

Timeframe: From enrollment to end of treatment at 4 months

Hair Density changes measured by SOCAi

Timeframe: From enrollment to the end of the study at 4 months

Increase in hair thickness assessed via Canfield HairMetrix® Phototrichogram Analysis

Timeframe: From enrollment to the end of treatment at 4 months

Trial details

NCT IDNCT07228156

SponsorRestore Biologics Holdings, Inc. dba Xtressé

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Thin Hair trials