Nutraceutical Supplements for Alopecia

Overseen By Emily Hu

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nutraceutical Wellness Inc.

Must not be taking: Finasteride, Minoxidil, Anticoagulants, others

Disqualifiers: Pregnancy, Alopecia, Thyroid disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 26 weeks

180 Participants Needed

Trial Summary

What is the purpose of this trial?

A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair.

Will I have to stop taking my current medications?

The trial requires participants to stop using any products or medications known to promote hair growth, like finasteride or minoxidil, at least 6 months before starting the study. If you are using hormones for birth control or hormone replacement therapy, you must have been on a stable dose for at least 6 months. Additionally, you cannot use any medications or medicated shampoos that might cause hair loss or affect hair growth.

What data supports the effectiveness of the treatment Nutrafol Women's Balance Hair Growth Supplement for alopecia?

Research shows that Nutrafol Women's Balance Hair Growth Supplement significantly increased hair growth and improved hair quality in women with thinning hair over a 6-month period. Participants experienced a notable increase in hair count and a reduction in hair shedding compared to those taking a placebo, with no reported adverse effects. ^{1 2 3 4 5}

Is Nutrafol Women's Balance Hair Growth Supplement safe for use?

The safety of products with phytoestrogenic activity, like some ingredients in Nutrafol, is not fully understood, and adverse reactions have been reported, including gastrointestinal and skin issues. Further investigation and careful monitoring are needed to ensure safety. ^{6 7 8 9 10}

How does the Nutrafol Women's Hair Growth Supplement treatment differ from other treatments for hair loss?

Nutrafol Women's Hair Growth Supplement is unique because it uses a blend of natural ingredients with anti-inflammatory, anti-stress, antioxidant, and hormone-inhibiting properties to promote hair growth and improve hair quality. Unlike some treatments that focus solely on hormonal factors, this supplement addresses multiple aspects of hair health, including stress and inflammation, and has shown significant improvements in hair growth and quality without reported adverse effects. ^{1 2 3 4 11}

Eligibility Criteria

This trial is for women experiencing hair loss, including conditions like Alopecia and Alopecia Areata. Participants should be interested in trying dietary supplements designed to promote hair growth.

Inclusion Criteria

Willing and able to adhere to the same dietary lifestyles for the duration of the study

I am a woman aged 18-70 with dermatologist-confirmed hair thinning.

General good health, as determined by the Investigator or qualified sub-investigator

Exclusion Criteria

I have a history of cancer other than skin cancer or am currently receiving cancer treatment.

Individuals who are pregnant, planning a pregnancy, nursing, or within 1-year post-partum

Individuals who have experienced serious complications due to COVID-19 previously or during the study as determined by the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutraceutical hair growth supplements and are monitored at baseline, 90 days, and 180 days

26 weeks

6 visits (in-person), 2 compliance phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nutrafol Women's Balance Hair Growth Supplement
• Nutrafol Women's Hair Growth Supplement
• Nutrafol Women's Postpartum Hair Growth Supplement
• Nutrafol Women's Vegan Hair Growth Supplement

Trial Overview The study tests four Nutrafol supplements: Vegan, Balance, Postpartum, and a general Hair Growth supplement. It aims to see if these products can improve thinning hair by addressing its root causes.

Participant Groups

Group I: Nutrafol Hair Growth Supplement Experimental Treatment 4 Interventions

4 commercially available hair growth nutraceuticals will be evaluated. Treatment groups will be assigned according to the investigator's discretion. Efficacy comparisons will not be made across treatment groups.

Nutrafol Women's Balance Hair Growth Supplement is already approved in United States for the following indications:

Approved in United States as Nutrafol Women's Balance for:

• Hair thinning in women before, during, and after menopause

Who Is Running the Clinical Trial?

Nutraceutical Wellness Inc.

Lead Sponsor

Trials

8

Recruited

1,000+

Findings from Research

A 6-month study involving 40 adult women showed that the nutraceutical supplement Nutrafol® significantly increased hair growth and quality, with improvements observed at both 90 and 180 days compared to a placebo.

The supplement was found to be safe, with no reported adverse events, and it effectively addressed hair loss by targeting inflammation, stress, and oxidative damage through its unique blend of active botanicals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. Ablon, G., Kogan, S.[2018]

In a 6-month study involving 70 perimenopausal, menopausal, and postmenopausal women, the nutraceutical supplement Nutrafol® Women’s Balance Capsules significantly increased hair counts and reduced hair shedding compared to a placebo, with notable improvements observed by day 90 and day 180.

The supplement was well-tolerated, indicating a favorable safety profile while effectively promoting hair growth and quality in women experiencing hair thinning due to menopause.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair. Ablon, G., Kogan, S.[2021]

Viviscal®, a nutraceutical supplement containing proteins, lipids, and glycosaminoglycans from marine sources, has been shown in clinical studies to effectively stimulate hair growth and reduce hair shedding.

The supplement is considered safe and is part of a multi-therapy approach to treat alopecia and thinning hair, which is particularly challenging to diagnose and manage in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments. Hornfeldt, CS., Holland, M., Bucay, VW., et al.[2015]

In a study of 10 adults with androgenetic alopecia, 80% showed improvement after 24 weeks of taking the oral supplement Forti5®, which includes ingredients like green tea extract and omega fatty acids.

The supplement led to a significant increase in terminal hair count (5.9%) and Hair Mass Index (9.5%), suggesting it may be an effective adjunct treatment for hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study. Nichols, AJ., Hughes, OB., Canazza, A., et al.[2020]

In a randomized, placebo-controlled study involving 15 healthy women over 180 days, an oral supplement significantly increased the number of terminal hairs in participants, with counts rising from 271 to 609.6 hairs compared to no change in the placebo group.

Participants taking the supplement reported noticeable improvements in hair volume, scalp coverage, and hair thickness, with no adverse events, indicating both safety and efficacy of the treatment for temporary hair thinning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning Hair. Glynis, A.[2021]

The EFSA Panel reconfirmed that EstroG-100™, a hot-water extract from three herbal roots, is safe for use in food supplements at a maximum intake of 175 mg/day for post-menopausal women, based on various toxicity studies.

Despite the applicant proposing a higher intake level of 514 mg/day, the Panel maintained its safety conclusion due to insufficient evidence on liver and haematological effects at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statement on the safety of EstroG-100™ as a novel food pursuant to Regulation (EC) No 258/97. Turck, D., Bresson, JL., Burlingame, B., et al.[2023]

In a study of 60 perimenopausal women, the use of nutraceuticals containing Equol, Resveratrol, Quercetin, and Passiflora significantly reduced menopause symptoms over 6 months, improving the modified Kupperman Index scores from 35 to 18.

The nutraceuticals also led to significant improvements in quality of life and sexual function by the second follow-up, with the Female Sexual Function Index score increasing from 23.1 to 27.6 and the Female Sexual Distress Scale score decreasing from 18.1 to 11.3, indicating enhanced sexual well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nutraceuticals on quality of life and sexual function of perimenopausal women. Caruso, S., Cianci, S., Cariola, M., et al.[2022]

The study identified that the most commonly reported plant species associated with adverse reactions (ARs) were black cohosh, hops, and soybean, indicating potential safety concerns with these phytoestrogenic products.

Adverse reactions were frequently related to gastrointestinal, skin, and reproductive system disorders, and there was a notable association between phytoestrogenic products and postmenopausal bleeding, highlighting the need for further research on their safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Safety Concerns on Herbal Products with Assumed Phytoestrogenic Activity. Tjeerdsma, AM., van Hunsel, FPAM., van de Koppel, S., et al.[2023]

The use of dietary supplements containing phyto-oestrogens, such as hop and soy, may lead to postmenopausal bleeding due to endometrial proliferation, as illustrated by four patient reports to the Netherlands Pharmacovigilance Centre.

Despite being available over-the-counter and perceived as safe, these herbal supplements can cause adverse drug reactions, highlighting the need for awareness among healthcare providers regarding their potential effects during diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postmenopausal bleeding and dietary supplements: a possible causal relationship with hop- and soy-containing preparations]. van Hunsel, FP., Kampschöer, P.[2012]

A study of 190 peri- and post-menopausal women in Bologna revealed that 79% used phytoestrogens primarily to alleviate hot flushes, with many reporting positive effects, especially long-term users who experienced greater relief from symptoms.

However, negative perceptions, such as edema, increased with long-term use, indicating that while phytoestrogens can be beneficial, monitoring for adverse effects is important for ongoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of phytoestrogens and effects perceived by postmenopausal women: result of a questionnaire-based survey. Girardi, A., Piccinni, C., Raschi, E., et al.[2022]

A 12-month study of a nutraceutical supplement showed significant improvements in hair growth and quality for women experiencing hair thinning, particularly beneficial for post-menopausal women.

Participants who initially received a placebo also experienced significant hair growth and reduced shedding after switching to the active supplement, indicating its long-term efficacy and potential positive effects on quality of life and menopausal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Long-Term Study of the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women. Ablon, G., Kogan, S., Raymond, I.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Six-Month, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Women With Self-Perceived Thinning Hair. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Double-Blind, Placebo-Controlled Study of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women With Thinning Hair. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A Double-blind, Placebo-controlled Study Evaluating the Efficacy of an Oral Supplement in Women with Self-perceived Thinning Hair. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Statement on the safety of EstroG-100™ as a novel food pursuant to Regulation (EC) No 258/97. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

Effects of nutraceuticals on quality of life and sexual function of perimenopausal women. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Analysis of Safety Concerns on Herbal Products with Assumed Phytoestrogenic Activity. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

[Postmenopausal bleeding and dietary supplements: a possible causal relationship with hop- and soy-containing preparations]. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Use of phytoestrogens and effects perceived by postmenopausal women: result of a questionnaire-based survey. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A Long-Term Study of the Safety and Efficacy of a Nutraceutical Supplement for Promoting Hair Growth in Perimenopausal, Menopausal, and Postmenopausal Women. [2022]