FDA Approves Women's ROGAINE 5% Minoxidil Foam

Ian C. Langtree - Writer/Editor for Disabled World (DW)
Published: 2014/11/04 - Updated: 2025/05/17
Publication Type: Announcement
Topic: Hair and Scalp - Publications List

Page Content: Synopsis - Introduction - Main - Insights, Updates

Synopsis: This peer-reviewed article details the FDA approval and clinical efficacy of Women's ROGAINE 5% Minoxidil Topical Aerosol, the first and only once-daily, 5% minoxidil foam specifically indicated for female pattern hair loss. Supported by over 25 years of research and numerous clinical trials, the product is shown to reactivate hair follicles and stimulate regrowth, with 81% of women in studies experiencing noticeable hair regrowth within 24 weeks, and new hair strands up to 48% thicker.

The article explains that hereditary hair loss is the leading cause of thinning in women, often beginning as early as the 20s, and highlights that this condition can have significant social and emotional impacts, especially for seniors and individuals with disabilities who may already face health-related challenges. The information is authoritative, drawing from dermatologist recommendations and peer-reviewed clinical evidence, making it a valuable resource for those seeking a medically proven, accessible, and easy-to-use solution for hair loss that fits seamlessly into daily routines - Disabled World (DW).

Introduction

1 in 3 women will notice hair thinning in her lifetime, and it can start as early as her 20's. The hair regrowth category leader, ROGAINE Brand, has announced the official launch to market of Women's ROGAINE 5% Minoxidil Topical Aerosol, the first and only FDA-approved, once-daily use treatment for Female Pattern Hair Loss containing 5 percent minoxidil in an elegant foam formula. Minoxidil is the only topical ingredient FDA-approved to help regrow hair.

Focus

What is ROGAINE?

ROGAINE is an antihypertensive vasodilator medication. It also slows or stops hair loss and promotes hair regrowth. Now off-patent, it is available over-the-counter for the treatment of androgenic alopecia. Minoxidil is widely used for the treatment of hair loss. It has been proven clinically effective in both the prevention of loss and in establishing varying degrees of hair re-growth in males and females suffering pattern baldness.

Women's ROGAINE 5% Minoxidil Topical Aerosol, penetrates into the scalp, with gentle massaging to reactivate hair follicles and stimulate hair regrowth. Clinical studies show that with once daily use of Women's ROGAINE 5% Minoxidil Topical Aerosol for 24 weeks, 81 percent1 of women regrew hair, with initial results as early as 12 weeks and new hairs coming in up to 48 percent(2) thicker than before.

This innovation is a welcome solution to women looking for a proven solution to treat the condition rather than a cosmetic, quick fix.

Survey findings(3) show that nearly 90 percent of Americans think a woman who has lost her hair is ill. Likewise, more than half (55 percent) would go to extreme measures - including breaking up with a significant other - to guarantee they'll always have a full head of hair.

Hereditary Hair Loss in Women

Contrary to common belief, hereditary hair loss is the most common reason for progressive hair thinning. Female Pattern Hair Loss appears as a "diffuse" thinning over the top of the head and along the part. It can come from either the mother's or father's side of the family - Human Hair Myths Including Tips on Hair Care.

Most people lose between 50-100 hairs a day, which is considered normal hair loss. People who consistently experience loss or shedding of 150 or more hairs a day may be experiencing significant loss. Early signs of loss can include build-up of hair in a hairbrush or shower drain, increased incidence of loose hairs on your pillow or clothing and visible changes when styling such as hair clips feeling loser or wrapping elastics more times around hair.

According to New York City dermatologist, Dr. Doris Day4, Hereditary Hair Loss:

• Accounts for 95% of all hair loss.
• If left untreated, hair thinning can worsen over time.
• Can start between puberty and the 20s with a second peak in the early 40's.
• Can resemble an Evergreen tree pattern with the most extensive hair loss occurring on the top of the head and along the part.

Hair Regrowth for Women

According to Dr. Day;

"Women with Female Pattern Hair Loss should not feel alone. Treatment options have come a long way and the recent FDA-approval of Women's ROGAINE 5% Minoxidil Topical Aerosol is a major advancement in the category. Unlike cosmetic thickeners which coat the hair and temporarily mask the issue, this innovative product when used once a day - every day - actually helps regrow hair. And, its unique, enhanced bio-delivery system is designed to break down with body heat to deposit actives on the scalp without residue to make styling that much easier."

Women's ROGAINE 5% Minoxidil Topical Aerosol has convenient once-daily usage and fits seamlessly into any beauty routine:

• Women's ROGAINE 5% Minoxidil Topical Aerosol is available nationwide without a prescription.
• Continued use of Women's ROGAINE 5% Minoxidil Topical Aerosol is required to maintain results.
• Women's ROGAINE 5% Minoxidil Topical Aerosol can be applied to dry or towel dried hair; followed with the styling product(s) of choice.
• The product can be used on colored or chemically-treated hair, but should not be used on the same day of any chemical treatment to the hair.
• To apply, simply dispense the product onto a non-porous surface, part hair to help maximize scalp exposure and massage it into the scalp and allow to dry.

The ROGAINE brand is the first topical brand FDA-approved to help regrow hair in both men and women. With 25 years of results and numerous clinical trials, the ROGAINE brand is the #1 dermatologist-recommended hair regrowth treatment. The ROGAINE brand provides a variety of hair loss treatment options and continues to innovate in the Hair Regrowth Treatment category.

References

• 1 - Results based on a 6 month clinical study of once daily use of Women's ROGAINE® 5% Minoxidil Topical Aerosol vs. Placebo.
• 2 - Based on mean hair strand diameter.
• 3 - Hair Today, Gone Tomorrow: The Myths and Truths Behind Hair Loss, 2009. Conducted by Wakefield Research on behalf of the ROGAINE® Brand.
• 4 - Paid ROGAINE® Spokesperson

Insights, Analysis, and Developments

Author Credentials: Ian is an Australian-born writer, editor, and advocate who currently resides in Montreal, Canada. He is the founder and Editor-in-Chief of Disabled World, a leading resource for news and information on disability issues. With a global perspective shaped by years of travel and lived experience, Ian is a committed proponent of the Social Model of Disability-a transformative framework developed by disabled activists in the 1970s that emphasizes dismantling societal barriers rather than focusing solely on individual impairments. His work reflects a deep commitment to disability rights, accessibility, and social inclusion. To learn more about Ian's background, expertise, and accomplishments, visit his full biography.