NCT07041489 · The Center for Clinical and Cosmetic Research
Evaluating the Combined Use of Supplement and Serum in Promoting Hair Growth in Women With Self-perceived Thinning Hair
What this study is about
The goal of this clinical trial is to test how safe and effective it is to improve hair growth using an active gummy and serum combination treatment when compared to an inactive treatment combination in women with self-perceived thinning hair.
View original scientific description
The goal of this clinical trial is to test how safe and effective it is to improve hair growth using an active gummy and serum combination treatment when compared to an inactive treatment combination in women with self-perceived thinning hair. The main questions this trial aims to answer are: * to confirm using photograph analytics, how much hair growth has increased in a marked area when using active treatment versus inactive treatment, and * participants assessment and satisfaction with the hair growth using scaled assessments. Participants who qualify will be asked to complete 6 to 7 visits after voluntarily consent has been given. The study is divided into two parts. In Part A participants will be randomly given either active or inactive treatment to use over 3 months. After 3 months, all participants will enter Part B of the study and will be given active treatment to use over the final 6 months of the study.
Interventions
DIETARY_SUPPLEMENT
Active Comparator- Xtressé™ Supplement and Serum
Participants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily. Participants in the Intervention group will receive Xtressé™ Supplements and Serum in Part A and Part B of the study. Participants in the Placebo Group will receive Xtressé™ Supplement and Serum in Part B of the study only.
DIETARY_SUPPLEMENT
Placebo Comparator- Placebo Supplement and Serum
Participants will receive 3 month supplies 3 times during the study. Participants will apply serum and take supplements daily. Participants in the Placebo Group will receive Placebo Supplement and Serum in Part A of the study only.
Primary outcome 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Birmingham, Alabama
- Aventura, Florida
Collaborators
Restore Biologics Holdings, Inc. dba Xtressé, Xtressé (TM)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 27, 2025 · Source of record for eligibility and locations