CLINICAL TRIALS PROFILE FOR ROGAINE (FOR MEN)

All Clinical Trials for Rogaine (for Men)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01309191 ↗	Microarray Analysis of Scalp Biopsies After Minoxidil Treatment	Completed	Kaiser Permanente	N/A	2011-04-01	The purpose of this study is to determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or androgenetic alopecia.
NCT01309191 ↗	Microarray Analysis of Scalp Biopsies After Minoxidil Treatment	Completed	University of California, San Francisco	N/A	2011-04-01	The purpose of this study is to determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or androgenetic alopecia.
NCT01309191 ↗	Microarray Analysis of Scalp Biopsies After Minoxidil Treatment	Completed	University Hospitals Cleveland Medical Center	N/A	2011-04-01	The purpose of this study is to determine whether Minoxidil treatment affects hair growth in patients with male pattern baldness or androgenetic alopecia.
NCT03488108 ↗	Platelet Rich Plasma Versus Minoxidil Foam for Treatment of Androgenic Alopecia in Women	Completed	Mayo Clinic	Phase 1/Phase 2	2017-01-23	The primary objective of this proposal is to conduct a study that assesses the safety, feasibility and efficacy of using PRP to treat this type of hair loss.
NCT03852992 ↗	Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia	Not yet recruiting	University of Minnesota	Phase 2	2021-09-01	The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. In this cohort study, patients will randomly be assigned stand-alone laser treatment, laser assisted drug delivery of minoxidil 2% solution, and laser assisted drug delivery of minoxidil 2% solution plus at home 5% minoxidil treatment. The primary endpoints will be to assess the change from baseline in investigator and subject Hair Growth Assessments (HGA), Hair Growth Index (HGI) and the Hair Growth Satisfaction Scale (HGSS) over 8-12 weeks in each of the three groups. The secondary endpoints will be expert assessment of hair density from baseline and evaluation of safety and adverse events, and pharmacokinetic (PK) data.
NCT03852992 ↗	Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia	Not yet recruiting	University of Minnesota - Clinical and Translational Science Institute	Phase 2	2021-09-01	The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. In this cohort study, patients will randomly be assigned stand-alone laser treatment, laser assisted drug delivery of minoxidil 2% solution, and laser assisted drug delivery of minoxidil 2% solution plus at home 5% minoxidil treatment. The primary endpoints will be to assess the change from baseline in investigator and subject Hair Growth Assessments (HGA), Hair Growth Index (HGI) and the Hair Growth Satisfaction Scale (HGSS) over 8-12 weeks in each of the three groups. The secondary endpoints will be expert assessment of hair density from baseline and evaluation of safety and adverse events, and pharmacokinetic (PK) data.

Clinical Trial Conditions for Rogaine (for Men)

Condition Name

Condition Name for Rogaine (for Men)
Intervention	Trials
Androgenetic Alopecia	2
Anatomic Stage IIA Breast Cancer AJCC v8	1
Male Pattern Hair Loss	1
Prognostic Stage IIIC Breast Cancer AJCC v8	1

Condition MeSH

Condition MeSH for Rogaine (for Men)
Intervention	Trials
Alopecia Areata	5
Alopecia	5
Ovarian Neoplasms	1
Carcinoma, Ovarian Epithelial	1

Clinical Trial Locations for Rogaine (for Men)

Trials by Country

Trials by Country for Rogaine (for Men)
Location	Trials
United States	6

Trials by US State

Trials by US State for Rogaine (for Men)
Location	Trials
Ohio	2
Illinois	1
North Carolina	1
Minnesota	1
Florida	1

Clinical Trial Progress for Rogaine (for Men)

Clinical Trial Phase

Clinical Trial Phase for Rogaine (for Men)
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Rogaine (for Men)
Clinical Trial Phase	Trials
Recruiting	2
Completed	2
Not yet recruiting	2

Clinical Trial Sponsors for Rogaine (for Men)

Sponsor Name

Sponsor Name for Rogaine (for Men)
Sponsor	Trials
University of Minnesota - Clinical and Translational Science Institute	1
The Skin of Color Society	1
Wake Forest University Health Sciences	1

Sponsor Type

Sponsor Type for Rogaine (for Men)
Sponsor	Trials
Other	11

Rogaine (Minoxidil) for Men: Clinical Trials, Market Analysis, and Projections

Introduction

Rogaine, commonly known by its active ingredient minoxidil, is a widely used treatment for androgenetic alopecia (AGA) in men. This article delves into the latest clinical trials, market analysis, and future projections for minoxidil, particularly focusing on its use in treating male pattern hair loss.

Clinical Trials: Oral vs Topical Minoxidil

Recent clinical trials have compared the efficacy of oral minoxidil with topical minoxidil in treating male AGA. A double-blind, placebo-controlled randomized clinical trial conducted in Brazil involved 90 men with AGA, who were randomized into two groups: one receiving daily oral minoxidil (5 mg) and the other receiving twice-daily topical minoxidil (5%)[1].

Key Findings

• The trial found that low-dose oral minoxidil (5 mg per day) had similar efficacy to topical minoxidil (5%) in terms of terminal hair density on the frontal and vertex regions of the scalp.
• Both treatments were well tolerated, and oral minoxidil did not demonstrate superiority over topical minoxidil after 24 weeks of treatment.
• This study suggests that oral minoxidil can be a viable option for patients who prefer oral therapy or are intolerant to topical treatments.

Market Analysis

The global minoxidil market is experiencing significant growth driven by several factors.

Market Size and Growth

• The global minoxidil market was valued at $1.9 billion in 2020 and is projected to reach $2.4 billion by 2025, with a compound annual growth rate (CAGR) of 4.3% during the period of 2020-2025[2][5].

Drivers of Growth

• The increasing prevalence of alopecia, particularly androgenetic alopecia, is a major driver of the market.
• The rising geriatric population and the growing number of cases of chronic diseases that can lead to hair loss also contribute to the market growth.
• Regional analysis indicates that the market is segmented into North America, Europe, Asia-Pacific, and the rest of the world, with detailed analysis of major countries such as the U.S., Germany, the U.K., and others[2][5].

Market Segmentation

By Type

• The minoxidil market is segmented into different concentrations such as 5%, 2%, and 10% minoxidil. The 5% concentration is the most commonly used for treating AGA[5].

By Form

• Minoxidil is available in both topical and oral forms. Topical minoxidil is the traditional and most widely used form, while oral minoxidil is gaining traction as an alternative[5].

By Application

• The primary application of minoxidil is in the treatment of alopecia, with a focus on androgenetic alopecia. It is also used to treat hair loss resulting from chronic diseases[5].

Future Projections and Developments

Emerging Treatments

• Besides minoxidil, other treatments are being developed for AGA. For example, Kintor Pharmaceuticals has completed a Phase II clinical trial for KX-826, an androgen receptor antagonist, which showed statistically and clinically meaningful results in treating male AGA[3].

Ongoing Clinical Trials

• Eurofarma Laboratorios S.A. has initiated a Phase 3 clinical trial on Minoxidil Topical Foam for the treatment of alopecia, expected to be completed by November 2024[3].

Patient Satisfaction and Efficacy

Topical Minoxidil Efficacy

• Studies have shown high patient satisfaction with topical minoxidil. For instance, a study on 5% minoxidil topical foam found that 75% of participants reported an improvement in their hair-loss condition after 24 weeks of treatment[4].

Photographic Evaluation

• Photographic evaluations have also supported the efficacy of minoxidil, with 50% of participants showing moderate improvement in hair growth after intervention[4].

Key Takeaways

• Clinical Trials: Oral minoxidil (5 mg) has been found to have similar efficacy to topical minoxidil (5%) in treating male AGA, offering an alternative for patients who prefer oral therapy.
• Market Growth: The global minoxidil market is projected to grow from $1.9 billion in 2020 to $2.4 billion by 2025, driven by increasing cases of alopecia and a rising geriatric population.
• Market Segmentation: The market is segmented by type, form, and application, with 5% minoxidil being the most commonly used concentration for AGA.
• Future Developments: New treatments like KX-826 and ongoing clinical trials for minoxidil topical foam are expected to further expand treatment options for AGA.

FAQs

1. What is the current market size of minoxidil, and what is its projected growth?

The global minoxidil market was valued at $1.9 billion in 2020 and is projected to reach $2.4 billion by 2025, with a CAGR of 4.3% during this period[2][5].

2. How effective is oral minoxidil compared to topical minoxidil in treating male AGA?

Oral minoxidil (5 mg) has been found to have similar efficacy to topical minoxidil (5%) in treating male AGA, making it a viable alternative for patients who prefer oral therapy[1].

3. What are the primary drivers of the minoxidil market growth?

The primary drivers include the increasing prevalence of alopecia, the rising geriatric population, and the growing number of cases of chronic diseases that can lead to hair loss[2][5].

4. Are there any new treatments being developed for AGA besides minoxidil?

Yes, treatments like KX-826, an androgen receptor antagonist, are being developed and have shown promising results in clinical trials[3].

5. What is the patient satisfaction rate with topical minoxidil treatment?

Studies have shown that up to 75% of participants reported an improvement in their hair-loss condition after using 5% minoxidil topical foam for 24 weeks[4].

Sources

1. Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia. JAMA Dermatology, 2024.
2. Global Minoxidil Market Report 2021. Business Wire, 2021.
3. Alopecia Treatment Market to Reach $14.16 Billion Globally by 2030. GlobeNewswire, 2023.
4. Efficacy and safety of 5% minoxidil topical foam in male pattern hair loss. Acta Dermatovenerol Alp Panonica Adriat, 2016.
5. Global Minoxidil Market 2020-2025. ResearchAndMarkets.com, 2021.