CLINICAL TRIALS PROFILE FOR MINOXIDIL EXTRA STRENGTH (FOR MEN)

505(b)(2) Clinical Trials for MINOXIDIL EXTRA STRENGTH (FOR MEN)

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 EXTRA STRENGTH (FOR MEN)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00876200 ↗	Efficacy of Minoxidil in Children With Williams-Beuren Syndrome	Completed	Hospices Civils de Lyon	Phase 2	2009-03-01	The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a multisystem developmental impairment. This syndrome is caused by a microdeletion in chromosome 7q11.23 that encompasses loss of the elastin locus. Elastin, which is part of the extracellular matrix, controls proliferation of vascular smooth muscle cells (VSMCs) and stabilizes arterial structure. Loss of elastin gene in WBS patients has been claimed to provide a biological basis for the abnormal elastic fibre properties leading to cardiovascular abnormalities like supravalvular aortic stenosis (SVAS), hypertension, arteriosclerosis and stenosis in more than 50% of WBS children. These cardiovascular pathologies result in important consequences and neither curative nor preventive medicinal treatments exist at this time. Surgery is needed in more than half cases, while it is often leading to complications. Minoxidil is a well-known antihypertensive drug used in adults and children. Furthermore, according to animal studies, minoxidil seems to increase arterial elastin content by decreasing elastase activity in these tissues. Other data demonstrate that minoxidil specifically stimulate elastin synthesis. Working Hypothesis:If insufficient elastin synthesis leads to vascular complications and arterial hypertension in children with WBS, restoration of sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial tension. Therefore, as a pharmacological agent capable to stimulate elastin expression, minoxidil might be a useful drug for the treatment of abnormal elastin metabolism in WBS children. Objective:To evaluate the efficacy of minoxidil on cardiovascular structure in children with Williams Beuren syndrome. Methodology: randomized controlled trial on two parallel group (23 patients in each arm) Main criterion:variation of carotid Intima-media thickness (IMT) before and after 12 months of treatment with Minoxidil versus placebo Secondary intermediate criteria of the vascular properties are arterial stiffness, cardiac and renal stenosis, arterial tension. Total study duration:30 months including a 12 month-recruitment period
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.
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.
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.
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.
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.

Clinical Trial Conditions for MINOXIDIL EXTRA STRENGTH (FOR MEN)

Condition Name

Condition Name for MINOXIDIL EXTRA STRENGTH (FOR MEN)
Intervention	Trials
Androgenetic Alopecia	21
Alopecia Areata	8
Alopecia	7
Female Pattern Hair Loss	6

Condition MeSH

Condition MeSH for MINOXIDIL EXTRA STRENGTH (FOR MEN)
Intervention	Trials
Alopecia	49
Alopecia Areata	48
Hypotrichosis	2
Hypertension	2

Clinical Trial Locations for MINOXIDIL EXTRA STRENGTH (FOR MEN)

Trials by Country

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Trials by Country for MINOXIDIL EXTRA STRENGTH (FOR MEN)
Location	Trials
United States	58
Egypt	9
Thailand	7
Germany	7
France	5

Trials by US State

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Trials by US State for MINOXIDIL EXTRA STRENGTH (FOR MEN)
Location	Trials
Texas	6
Minnesota	5
Ohio	5
Oregon	4
Florida	4

Clinical Trial Progress for MINOXIDIL EXTRA STRENGTH (FOR MEN)

Clinical Trial Phase

Clinical Trial Phase for MINOXIDIL EXTRA STRENGTH (FOR MEN)
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	11
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for MINOXIDIL EXTRA STRENGTH (FOR MEN)
Clinical Trial Phase	Trials
Completed	33
Recruiting	10
Not yet recruiting	8

Clinical Trial Sponsors for MINOXIDIL EXTRA STRENGTH (FOR MEN)

Sponsor Name

Sponsor Name for MINOXIDIL EXTRA STRENGTH (FOR MEN)
Sponsor	Trials
Mae Fah Luang University Hospital	5
Assiut University	4
Cairo University	2

Sponsor Type

Sponsor Type for MINOXIDIL EXTRA STRENGTH (FOR MEN)
Sponsor	Trials
Other	57
Industry	23
U.S. Fed	2

Minoxidil Extra Strength for Men: Clinical Trials, Market Analysis, and Projections

Introduction to Minoxidil

Minoxidil, a potent vasodilator, has been widely used for the treatment of hair loss, particularly androgenetic alopecia (AGA). Its efficacy in promoting hair growth and reducing hair loss has made it a staple in the hair care industry.

Clinical Trials and Efficacy

Topical Minoxidil Formulations

Several clinical trials have compared the efficacy of different concentrations of topical minoxidil. A randomized, self-comparative clinical trial involving 66 patients with AGA found that a 15% minoxidil solution significantly outperformed a 5% solution in terms of hair growth parameters at weeks 12 and 24. There was no significant difference in adverse effects between the two groups[4].

Another study, a placebo-controlled, double-blind trial involving 90 men with AGA, compared minoxidil 5% and 10% solutions against a placebo. The results showed that the 5% minoxidil solution was more effective in improving hair regrowth compared to the 10% solution and the placebo[4].

Oral Minoxidil

Oral minoxidil has also been explored as an alternative or complementary treatment to topical minoxidil. A review of 1,404 Cleveland Clinic patients on low-dose oral minoxidil showed positive results, with nearly 80% experiencing no adverse effects. However, common side effects included hypertrichosis (15.1%), and systemic adverse effects such as light-headedness, fluid retention, and tachycardia affected about 5.5% of the patients. Despite these side effects, most patients were able to continue treatment with dosage adjustments[1].

Market Analysis

Global Market Size and Growth

The global minoxidil market is estimated to be valued at US$ 1,095.5 million in 2023 and is expected to exhibit a compound annual growth rate (CAGR) of 4.8% during the forecast period from 2023 to 2030[3].

U.S. Market Size and Growth

In the United States, the minoxidil market size surpassed USD 600 million in 2020 and is projected to grow at a CAGR of over 4.35% from 2021 to 2027. This growth is driven by an increasing number of individuals with hair loss problems and a rising demand for hair care products[2][5].

Market Segmentation

The minoxidil market is segmented by product and region. The 5% concentration segment is expected to grow at over 5% CAGR from 2023 to 2032, driven by its widespread use in various hair care formulations. The North American market, in particular, is projected to be worth over USD 1.3 billion by 2032, driven by the increasing prevalence of baldness, scanty scalp, and premature hair loss in the region[5].

Market Projections

Future Growth Drivers

The minoxidil market is expected to continue its growth trajectory due to several factors:

• Increasing Consumer Expenditure: Rising consumer spending on hair care products is a significant driver. The easy access to these products through a broad distribution network, including online pharmacies and large retail pharmacy chains, will foster market development[5].
• Expanding Distribution Channels: The growing e-commerce sector, especially due to the trend of e-prescriptions and lockdown measures during the pandemic, has boosted sales through online channels[5].
• Research and Development: Ongoing research and development activities, including the potential use of minoxidil for treating late alopecia in cancer patients, are expected to drive market growth[3].

Challenges and Pitfalls

Despite the positive outlook, there are challenges to consider:

• Adverse Effects: While minoxidil is generally well-tolerated, side effects such as hypertrichosis, light-headedness, and fluid retention can occur. Medical oversight is crucial to manage these effects effectively[1].
• Consumer Preferences: Some consumers may discontinue treatment due to aversion to topical treatments or perceived lack of efficacy, which can impact market growth[4].

Competitive Landscape

The minoxidil market is competitive, with several key players operating in the industry. These companies are focusing on increasing their physical presence, collaborating with specialists, and expanding their distribution networks to capture a larger market share[5].

Key Takeaways

• Clinical Efficacy: Minoxidil, especially in higher concentrations like 15%, has shown significant efficacy in promoting hair growth and reducing hair loss.
• Market Growth: The global and U.S. minoxidil markets are expected to grow at a CAGR of 4.8% and 4.35%, respectively, driven by increasing demand for hair care products.
• Distribution and Sales: The expansion of distribution channels, including online pharmacies and retail chains, is a key factor in market growth.
• Research and Development: Ongoing research into new uses for minoxidil, such as treating late alopecia in cancer patients, will drive future market growth.

FAQs

What are the common side effects of minoxidil?

Common side effects of minoxidil include hypertrichosis, light-headedness, fluid retention, tachycardia, headache, periorbital edema, and insomnia. However, most patients can continue treatment with dosage adjustments[1].

How effective is oral minoxidil compared to topical minoxidil?

Oral minoxidil has shown positive results, especially for patients who do not respond well to topical treatments. However, it requires medical oversight due to potential systemic side effects[1].

What is the projected market size of the U.S. minoxidil market by 2027?

The U.S. minoxidil market is projected to grow at a CAGR of over 4.35% from 2021 to 2027, with the market size expected to continue its upward trend[2][5].

Which concentration of minoxidil is most effective?

Clinical trials have shown that higher concentrations of minoxidil, such as 15%, are more effective than lower concentrations like 5% in promoting hair growth[4].

What are the key drivers of the minoxidil market growth?

Key drivers include increasing consumer expenditure on hair care products, expanding distribution channels, and ongoing research and development activities[3][5].

Sources

1. Consult QD: Oral Minoxidil Offers Strong Results Against Alopecia.
2. SkyQuest: U.S. Minoxidil Market Size, Share, Growth Analysis.
3. Coherent Market Insights: Minoxidil Market Size, Trends and Forecast to 2030.
4. Oxford Academic: Does topical minoxidil at concentrations higher than 5% provide additional benefits?
5. Global Market Insights: Minoxidil Market Share, 2023-2032 | Industry Forecast Report.