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

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Study AimThis 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

Hair Thinning

From 28 to 65 Years
+17 Eligibility Criteria

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: June 27, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: May 20, 2025Actual 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 
Principal SponsorThe Center for Clinical and Cosmetic Research
Study ContactMark S. Nestor, MD, PhD
Last updated: June 27, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 28 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hair Thinning
Criteria
7 inclusion criteria required to participate
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

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10 exclusion criteria prevent from participating
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)

Show More Criteria

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
Placebo
42 subjects will be randomized to this group and will receive Placebo supplements and serum in only Part A of the study.
Group III
Active Comparator
42 subjects will enter the open-labelled Part B of the study and will receive Xtressé™ supplements + serum.
Study Objectives
Primary Objectives

Quantitative hair measurements calculated by analyzing the participants digital images.

Quantitative hair measurements calculated by analyzing the participants digital images.

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.
Secondary Objectives

Changes to the appearance of hair will be captured using the SOCAi system.

Observations and changes noted in hair quality graded on a scale of -3 to +3, with -3 as greatly worsened/ decreased, 0 as no change and +3 as significantly increased/ improved.

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 DermatologyBirmingham, United StatesSee the location
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Center for Clinical and Cosmetic ResearchAventura, United States
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2 Study Centers