What are the FDA-approved treatment options for androgenic alopecia in males and females?

FDA-Approved Treatments for Androgenetic Alopecia

For males, the FDA has approved topical minoxidil (2% and 5% solutions) and oral finasteride (1 mg daily), while for females, only topical minoxidil (2% and 5% solutions) is FDA-approved. 1, 2, 3

Male Androgenetic Alopecia: FDA-Approved Options

First-Line: Topical Minoxidil

• Topical minoxidil 5% solution applied twice daily is FDA-approved and demonstrates superior hair regrowth compared to minoxidil 2% 1, 2
• The FDA label specifies that minoxidil 5% is for use only by men aged 18 years and older, applied directly to the scalp twice daily 1
• Results may appear as early as 2 months, but most men require at least 4 months of continuous use to see meaningful regrowth 1
• Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials without continuous treatment 1
• Treatment must be continued indefinitely, as discontinuation leads to reversal of hair growth benefits within months 4

Second FDA-Approved Option: Oral Finasteride

• Oral finasteride 1 mg daily is FDA-approved specifically for male pattern baldness 5, 2, 3
• Meta-analysis confirms finasteride is superior to placebo (P < .00001) for promoting hair growth in men 2
• The FDA label documents sexual dysfunction adverse effects, including erectile dysfunction, decreased libido, and ejaculation disorders that may persist after discontinuation in rare cases 5
• Finasteride is associated with rare cases of male breast cancer and requires patient counseling about potential sexual side effects 5

Third FDA-Cleared Option: Low-Level Laser Light Therapy

• Low-level laser light therapy (HairMax LaserComb) is FDA-cleared for male androgenetic alopecia 2, 6
• Meta-analysis demonstrates superiority to placebo (P < .00001) for hair growth 2

Female Androgenetic Alopecia: FDA-Approved Options

Only FDA-Approved Treatment: Topical Minoxidil

• Topical minoxidil is the only FDA-approved medication for female pattern hair loss, with both 5% foam applied once daily and 2% solution applied twice daily showing significant efficacy 4, 1, 7
• The FDA label explicitly states that women should not use minoxidil 5% solution because studies showed it works no better than 2% in women, and some women may develop unwanted facial hair 1
• Minoxidil 5% foam formulation (once daily) or 2% solution (twice daily) are the appropriate FDA-approved options for women 4
• Meta-analysis confirms 2% minoxidil is superior to placebo (P < .00001) in women with androgenetic alopecia 2
• Treatment must be continued indefinitely to maintain benefits 4, 8

Important FDA Contraindication

• The FDA label specifies that minoxidil topical solution may be harmful if used during pregnancy or breast-feeding 1

Critical Clinical Considerations

Monitoring and Timeline

• Evaluate treatment response at 3 months initially, with meaningful changes potentially taking 12-24 months for combination therapies 8
• Use standardized photographs, trichoscopy, hair pull tests, and patient self-assessment questionnaires to objectively measure response 4, 8

Common Pitfall to Avoid

• Patients may experience temporary increased hair shedding for up to 2 weeks when starting minoxidil—this is expected as old hairs are shed to make way for new growth and should not prompt discontinuation 1
• Stopping treatment prematurely before 4 months prevents adequate assessment of efficacy 8, 1

Non-FDA-Approved but Evidence-Based Adjunct

• While not FDA-approved, platelet-rich plasma (PRP) combined with topical minoxidil 5% demonstrates superior efficacy compared to either treatment alone and represents the most effective evidence-based approach when resources permit 4, 8
• The recommended protocol involves 3-5 monthly PRP sessions initially, followed by maintenance every 6 months 8