Evaluating Nutraceutical Supplements for Hair Growth in Women

A Single-center, Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females With Self-Perceived Thinning Hair

This study is testing whether certain hair growth supplements can help women with thinning hair grow it back over six months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Nutraceutical Wellness Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Sacramento, California)
• Trial ID: NCT06376409 on ClinicalTrials.gov

What this trial studies

This study is an open-label interventional evaluation of commercially available nutraceutical supplements aimed at addressing hair thinning in females. A total of 180 subjects will be enrolled, divided into four groups based on the specific hair growth supplement they receive. Participants will undergo multiple visits over 180 days to assess hair growth and compliance, with data compared to baseline measurements. The study aims to identify the effectiveness of these supplements in promoting hair growth.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-70 with self-perceived hair thinning confirmed by a dermatologist.

Not a fit: Patients with severe underlying medical conditions affecting hair growth or those not willing to adhere to dietary restrictions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide women with effective nutraceutical options for improving hair growth and addressing thinning hair.

How similar studies have performed: While there have been studies on hair growth supplements, this specific evaluation of nutraceuticals in a structured format is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Females of all Fitzpatrick skin, and hair types between 18-70 years of age with self-perceived thinning, confirmed by a dermatologist.
2. Willing and able to adhere to the same dietary lifestyles for the duration of the study.
3. Able to understand and sign an informed consent agreement and photo release form approved by the Institutional Review Board
4. General good health, as determined by the Investigator or qualified sub-investigator.
5. Willing and able to attend all study visits and comply with the test product daily instructions.
6. Willing to use a mild non-medicated shampoo and conditioner for the duration of the study (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth).
7. Willing and able to cooperate with the requirements of the study.
8. Able to complete and understand the various questionnaires.

Exclusion Criteria:

1. Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year post-partum.
2. Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator.
3. Clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia.
4. Individuals who have had a history of any acute or chronic disease that could interfere with or increase the risk on study participation.
5. Individuals who have had a history of any acute or chronic medical or hair condition that could affect study results, such as a history of disordered eating.
6. Scalp hair loss on the treatment area, due to disease, injury, or medical therapy.
7. Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), infection, cuts, and/ or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator or qualified sub-investigator, might put the subject at risk or interfere with the study conduct or evaluations.
8. History of surgical correction of hair loss on the scalp (i.e., hair transplant).
9. Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 6 months prior to the Baseline Visit.
10. Females who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study (the initiation of HRT or birth control should not have been associated with the initiation of hair loss/thinning).
11. History of malignancy (except cutaneous squamous cell carcinoma and basal cell carcinoma) or currently undergoing chemotherapy or radiation treatments.
12. A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that in the opinion of the Investigator or qualified sub-investigator may interfere with the study treatment.
13. A known history of unstable or chronic depression or bipolar disease or any other condition that may impact the subject's participation in the opinion of the investigator or qualified sub-investigator.
14. A known allergy to any of the ingredients in the investigational product.
15. Utilization of low-level lasers for hair growth in the last three months.
16. Any condition that the Investigator thinks may put the subject at risk or interfere with their participation in the study or study results.
17. Known history of or current iron deficiency, bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage \>20 cigarettes/day as reported by the subject.
18. Use of any medications or medicated shampoos that are known to potentially cause hair loss or affect hair growth, as determined by the Investigator or qualified sub-investigator.

Where this trial is running

Sacramento, California

• Integrative Skin Science and Research — Sacramento, California, United States (Recruiting)

Study contacts

• Study coordinator: Emily Hu

Conditions Hair Thinning