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Evaluating Xtressé™ Supplement and Serum for Hair Thinning

This study is testing a combination of Xtressé™ Supplement and Serum to see if it can help women with self-perceived thinning hair. Researchers want to find out how well this active treatment works compared to an inactive treatment (placebo). They will measure changes in hair density (how many hairs per square centimeter) and ask participants about their satisfaction with hair growth. You might be able to join if you are a woman between 28 and 65 years old with mild to moderate thinning hair. The study aims to confirm hair growth using special photographs and understand participants' experiences.

Study design
This is an interventional study with a planned enrollment of 85 women. Participants will be randomly assigned to receive either the active treatment or a placebo.
What's involved
You would have 6 to 7 visits and use the serum and supplement daily for up to 9 months. This includes providing medical history, undergoing exams, and allowing photographs of your scalp.
Compensation
Not stated in the trial record.
Follow-up
Hair density and participant satisfaction will be measured for up to 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07041489

Evaluating the Combined Use of Supplement and Serum in Promoting Hair Growth in Women With Self-perceived Thinning Hair

Recruiting
NAAges 28–65InterventionalTreatment
The Center for Clinical and Cosmetic Research
~85 participants
Updated 2025-06-27 on ClinicalTrials.gov
What's tested:Active Comparator- Xtressé™ Supplement and SerumPlacebo Comparator- Placebo Supplement and Serum

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Increase in hair density (hairs per cm²) measured as the within-subject change from baseline to Month 3, assessed via Canfield HairMetrix® phototrichogram analyses.
Measured over an average of 3 months
+2 more outcomes measured

Conditions

Hair Thinning

Explore related trials

Alopecia

Where it's being run

2 sites across 2 states
Alabama1
Florida1

Study leadership

  • Danielle Leavitt · STUDY_DIRECTOR · Restore Biologics Holdings, Inc. dba Xtressé

Who to contact

Mark S. Nestor, MD, PhD
[email protected]
305-933-6716
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Female adults between 28-65 years of age with consistent self-perceived thinning hair.
Ludwig Scale I or II (mild to moderate thinning hair loss), assessed clinically.
Fitzpatrick Skin Types I to VI.
Agree to maintain their current diet, medications, 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 and commitment to effective contraception throughout the study (oral / implant/ injectable/ transdermal contraceptives, intrauterine device, condom, diaphragm, abstinence, or a monogamous relationship with a partner who has had a vasectomy) to avoid pregnancy-related hormonal changes affecting hair density.

Exclusion

Pregnant or lactating or planning to become pregnant.
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 study start and throughout the study.
Micro-needling, PRP, or any other physical treatment modality on the scalp (within 6 months prior to study start and throughout the study).
Use of GLP-1 inhibitors (e.g., Semaglutide) within 6 months prior to study start and throughout the study.
Known uncontrolled health conditions (e.g., thyroid disease, anemia) that could confound study outcomes.
Known sensitivity to any of the ingredients in the study medication.
In the investigator's opinion, evidence of unwillingness, or inability to follow the restrictions and requirements of the protocol and complete the study.
Subject has any conditions, findings in history, physical exam or laboratory assessments, which in the opinion of the investigator, would exclude the subject from continuing in this study.
Treatment with an experimental drug, biologic or device within 12 weeks of the screening visit.

What this trial measures

  • Increase in hair density (hairs per cm²) measured as the within-subject change from baseline to Month 3, assessed via Canfield HairMetrix® phototrichogram analyses.an average of 3 months

    Quantitative hair measurements calculated by analyzing the participants digital images.

  • Increase in hair density (hairs per cm²) Measured as the within-subject change from baseline to Month 9, assessed via Canfield HairMetrix® phototrichogram analyses.Up to 9 months

    Quantitative hair measurements calculated by analyzing the participants digital images.

  • Participant self-assessment of hair growth and satisfaction, collected via validated questionnaires.Up to 9 months

    Observations and changes noted in hair loss graded on a scale of 0 to 4, with 0 as none and 4 as a very severe outcome. Observations and changes noted in quality of life based on hair loss, outcomes graded between extremely affected and not at all.