Recruiting

Xtressé™ Supplement and Serum Treatment for Hair Growth in Women with Thinning Hair

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Study Aim

This study is about treating women with thinning hair using Xtressé™ Supplement and Serum. We will measure changes in hair density at 3 and 9 months, and gather your feedback on hair growth and satisfaction.

What is being tested

Active Comparator- Xtressé™ Supplement and Serum

+ Placebo Comparator- Placebo Supplement and Serum

Dietary Supplement
Who is being recruted

Alopecia+3

+ Alopecia Areata

+ Hair Diseases

From 28 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorThe Center for Clinical and Cosmetic Research
Study ContactMark S. Nestor, MD, PhD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: May 20, 2025

Actual date on which the first participant was enrolled.

This study aims to explore the effectiveness and safety of a combination treatment involving Xtressé™ supplement and serum to promote hair growth in women who feel they have thinning hair. Women between the ages of 28 to 65 who have noticed a decrease in their hair thickness are eligible to participate. This research is important because it could provide a new solution for women experiencing this common issue, potentially improving their quality of life and self-confidence if the treatment proves to be successful. Participants in the study will need to provide personal and medical information, undergo certain medical exams, and follow specific guidelines throughout the study. They will apply the serum and consume a gummy treatment each day, keeping a diary of their treatment routine. Clinical assessments will involve photographs and measurements of hair density, focusing on a marked area on the scalp. The study also requires participants to avoid other hair treatments and maintain their current hair care routine. Participants are free to leave the study at any time if they choose.

Official TitleA Multi Center, Randomized, Double-Blind, Placebo-controlled Trial With Extension to an Open-Label Study to Evaluate the Safety and Efficacy of Xtressé™ Supplement + Serum Treatment Combination in Promoting Hair Growth in Women With Self-perceived Thinning Hair 
NCT07041489
Principal SponsorThe Center for Clinical and Cosmetic Research
Study ContactMark S. Nestor, MD, PhD
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

85 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 28 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlopeciaAlopecia AreataHair DiseasesHypotrichosisSkin DiseasesPathological Conditions, Anatomical

Criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
43 subjects will be randomized to this group and will receive Xtressé™ supplements + serum during the double-blinded Part A and open-label Part B of the study.

Group II

Active Comparator
42 subjects will enter the open-labelled Part B of the study and will receive Xtressé™ supplements + serum.

Group III

Placebo
42 subjects will be randomized to this group and will receive Placebo supplements and serum in only Part A of the study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Skin Wellness Dermatology

Birmingham, United StatesSee the location
Recruiting

Center for Clinical and Cosmetic Research

Aventura, United States
Recruiting
2 Study Centers