CLINICAL TRIALS PROFILE FOR MINOXIDIL (FOR WOMEN)

505(b)(2) Clinical Trials for Minoxidil (for Women)

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01325337 ↗	Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia	Completed	Allergan	Phase 2	2011-06-01	This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.
OTC	NCT01325350 ↗	Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss	Completed	Allergan	Phase 2	2011-06-01	This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.

All Clinical Trials for Minoxidil (for Women)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00151515 ↗	A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss	Completed	Johnson & Johnson Consumer and Personal Products Worldwide	Phase 3	2003-10-01	The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.
NCT00175617 ↗	Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss	Completed	University of British Columbia	Phase 2	2005-09-01	This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.
NCT00418730 ↗	Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss	Completed	Neosil, Inc.	Phase 2	2007-01-01	The purpose of this study is to measure the hair growth response to topical NEOSH101 when applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will participate. Three equally sized treatment groups (60 men each) will receive either topical NEOSH101 2.0%, minoxidil 5%, or placebo.
NCT00607477 ↗	Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension	Terminated	University of Chicago	N/A	2008-01-01	The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.

Clinical Trial Conditions for Minoxidil (for Women)

Condition Name

Condition Name for Minoxidil (for Women)
Intervention	Trials
Androgenetic Alopecia	21
Alopecia Areata	8
Alopecia	7
Female Pattern Hair Loss	6

Condition MeSH

Condition MeSH for Minoxidil (for Women)
Intervention	Trials
Alopecia	49
Alopecia Areata	48
Hypotrichosis	2
Hypertension	2

Clinical Trial Locations for Minoxidil (for Women)

Trials by Country

Trials by Country for Minoxidil (for Women)
Location	Trials
United States	58
Egypt	9
Thailand	7
Germany	7
France	5

Trials by US State

Trials by US State for Minoxidil (for Women)
Location	Trials
Texas	6
Minnesota	5
Ohio	5
Oregon	4
Florida	4

Clinical Trial Progress for Minoxidil (for Women)

Clinical Trial Phase

Clinical Trial Phase for Minoxidil (for Women)
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	11
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Minoxidil (for Women)
Clinical Trial Phase	Trials
Completed	33
Recruiting	10
Not yet recruiting	8

Clinical Trial Sponsors for Minoxidil (for Women)

Sponsor Name

Sponsor Name for Minoxidil (for Women)
Sponsor	Trials
Mae Fah Luang University Hospital	5
Assiut University	4
Johnson & Johnson Consumer and Personal Products Worldwide	2

Sponsor Type

Sponsor Type for Minoxidil (for Women)
Sponsor	Trials
Other	57
Industry	23
U.S. Fed	2

Minoxidil for Women: Clinical Trials, Market Analysis, and Projections

Introduction to Minoxidil

Minoxidil is a widely recognized treatment for hair loss, particularly effective in addressing androgenetic alopecia, also known as female pattern hair loss. Here, we will delve into the clinical trials, market analysis, and future projections for minoxidil, focusing on its use in women.

Clinical Trials and Efficacy

Key Clinical Trial Findings

A significant clinical trial published in 2004 involved 381 women with female pattern hair loss. This 48-week, double-blind, placebo-controlled, randomized trial compared the efficacy and safety of 5% topical minoxidil, 2% topical minoxidil, and a placebo. The results showed that 5% topical minoxidil was superior to the placebo in all three primary efficacy measures: nonvellus hair count, patient assessment of hair growth, and investigator assessment of hair growth/scalp coverage. The 2% minoxidil group also demonstrated superiority over the placebo in hair count and investigator assessment, although patient assessments were not significantly different from the placebo[1].

Safety and Side Effects

Both concentrations of minoxidil were well-tolerated, but the 5% solution had a higher incidence of side effects such as pruritus, local irritation, and hypertrichosis compared to the 2% solution and placebo. Despite these side effects, there was no evidence of systemic adverse effects[1].

Use in Breast Cancer Patients

A recent study on women with breast cancer found that low oral doses of minoxidil can safely promote hair growth without causing significant heart-related side effects. This study, conducted by researchers at NYU Langone Health, involved 51 women and showed improvements in hair growth or stabilization of hair loss within three to six months of starting the therapy[4].

Market Analysis

Current Market Size and Growth

The U.S. minoxidil market exceeded USD 600 million in 2020 and is projected to grow at a compound annual growth rate (CAGR) of over 4.35% between 2021 and 2027. The global minoxidil market is also expected to grow, from $1.9 billion in 2020 to $2.4 billion by 2025, with a CAGR of 4.3% during this period[2][5].

Market Segmentation

The market is segmented based on formulation, with 2% and 5% concentrations being the most common. The 2% formulation is particularly popular for treating hair loss in women, while the 5% concentration is also used for male pattern baldness. The market is also segmented by form (topical and oral) and application (alopecia and chronic diseases)[5].

Retail Pharmacies and Consumer Demand

Retail pharmacies are expected to play a significant role in the growth of the minoxidil market, with projected growth to about USD 460 million by 2027. The convenience of home delivery and the availability of generic medications in retail pharmacies are key factors driving this growth. Increasing consumer focus on health and wellness, along with rising demand for hair growth products, is also anticipated to boost the market[2].

Market Projections

Global Market Forecast

The global minoxidil market is forecast to reach $2.4 billion by 2025, driven by the increasing prevalence of alopecia, particularly androgenetic alopecia, and the rising geriatric population. Other factors contributing to this growth include the launch of novel products and ongoing research and development[5].

U.S. Market Forecast

In the U.S., the minoxidil market is expected to continue growing, driven by consumer demand for hair care products that enhance hair strength and volume. The market is projected to grow at a CAGR of over 4.35% between 2021 and 2027, with significant contributions from retail pharmacies[2].

Consumer Trends and Drivers

Increasing Awareness and Demand

There is a rising consumer inclination towards hair treatments for aesthetic purposes, which has led to increased awareness and demand for hair loss products. The use of high heat hair tools, various hairstyles, and stress have all contributed to hair loss issues in women, further driving the demand for minoxidil[2].

Health and Wellness Focus

The increasing focus on health and wellness among consumers is expected to boost demand for quality healthcare products, including minoxidil. This trend is particularly significant in the context of busy lifestyles and hectic work schedules, where convenience and effectiveness are highly valued[2].

Challenges and Opportunities

Side Effects and Safety Concerns

One of the main challenges facing the minoxidil market is the potential side effects associated with its use, such as pruritus, local irritation, and hypertrichosis. However, studies have shown that these side effects are generally manageable and do not lead to systemic adverse effects[1].

Ongoing Research and Development

Ongoing R&D and the launch of novel products are expected to provide opportunities for market growth. For instance, the study on the safety and efficacy of low oral doses of minoxidil in breast cancer patients opens up new avenues for the use of minoxidil in different patient populations[4].

Key Takeaways

• Clinical Efficacy: Minoxidil, particularly the 5% concentration, has been shown to be highly effective in treating female pattern hair loss.
• Market Growth: The global and U.S. minoxidil markets are projected to grow significantly, driven by increasing consumer demand and the rising prevalence of alopecia.
• Consumer Trends: Rising awareness and demand for hair care products, along with a focus on health and wellness, are key drivers of the market.
• Challenges and Opportunities: While side effects are a concern, ongoing R&D and the launch of new products offer opportunities for market expansion.

FAQs

Q: What are the primary efficacy measures in clinical trials for minoxidil in women?

A: The primary efficacy measures include change in nonvellus hair count, patient assessment of hair growth, and investigator assessment of hair growth/scalp coverage[1].

Q: Is minoxidil safe for use in breast cancer patients?

A: Yes, low oral doses of minoxidil have been found to be safe and effective in promoting hair growth in breast cancer patients without significant heart-related side effects[4].

Q: What is the projected growth rate of the U.S. minoxidil market?

A: The U.S. minoxidil market is projected to grow at a CAGR of over 4.35% between 2021 and 2027[2].

Q: What are the common side effects associated with minoxidil use?

A: Common side effects include pruritus, local irritation, and hypertrichosis, particularly with the 5% concentration[1].

Q: How does the global minoxidil market size compare to the U.S. market?

A: The global minoxidil market is expected to reach $2.4 billion by 2025, while the U.S. market exceeded $600 million in 2020 and is projected to continue growing[2][5].

Sources

1. Lucky, A. W., Piacquadio, D. J., Ditre, C. M., Dunlap, F., Kantor, J., & Kraus, S. J. (2004). A randomized, placebo-controlled trial of 5% and 2% topical minoxidil solutions in the treatment of female pattern hair loss. Journal of the American Academy of Dermatology, 50(4), 541-553.
2. GMI Insights. (n.d.). U.S. Minoxidil Market Size and Share | Statistics - 2027. Retrieved from https://www.gminsights.com/industry-analysis/us-minoxidil-market
3. GlobeNewswire. (2023, December 7). Alopecia Treatment Market to Reach $14.16 Billion, Globally by 2030 at 5.6% CAGR. Retrieved from https://www.globenewswire.com/news-release/2023/12/07/2792258/0/en/Alopecia-Treatment-Market-to-Reach-14-16-Billion-Globally-by-2030-at-5-6-CAGR-Coherent-Market-Insights.html
4. Medical Xpress. (2024, December 9). Hair growth drug can be safe at low doses for breast cancer patients, study finds. Retrieved from https://medicalxpress.com/news/2024-12-hair-growth-drug-safe-doses-breast-cancer.html
5. Research and Markets. (n.d.). Global Minoxidil Market 2020-2025. Retrieved from https://www.researchandmarkets.com/reports/5350186/global-minoxidil-market-2020-2025