Approximately 50% of adults worldwide experience hair loss, leading to both medical and psychosocial complications that can best be managed with a group of options (American Academy of Dermatology, 2024). Traditional therapies, including finasteride and minoxidil, have been the mainstay of care. Recent therapies are being studied and show potential to support hair regrowth in some patients, though effectiveness differs individually. Understanding the underlying causes of androgenetic alopecia can help patients make informed treatment decisions.
FDA-Approved Hair Loss Treatments
Minoxidil and Finasteride: Established Options
Since its FDA approval for male use in 1988 and for female use in 1991, minoxidil has been an important agent for the treatment of hair loss (Stevens et al., 2022). Clinical studies have shown that topical minoxidil preparations aid in improving hair density, and there is now new data supporting that low-dose oral formulations may also be effective.
One study in 2019 found that taking 1mg of oral minoxidil daily led to a mean increase in hair density of 12%, compared to only 7.2% when taking the topical product, over a period of 24 weeks (American Hair Research Society, 2024).
Finasteride (Propecia®) was also FDA approved for treatment of male pattern baldness in 1997, and has shown to be effective in hair regrowth in ~61 to 66% of males who are bald in the crown area (Cleveland Clinic, 2024). In clinical studies, it has also been shown to produce a mean 10-20% hair density increase within the first year of usage. Upon evaluation, ~80% of males reported no loss of existing hair density at 5 years. Finasteride operates by inhibiting the enzyme (5-alpha-reductase) that converts testosterone to the more active androgen dihydrotestosterone (DHT), which has been identified as relevant in the diagnosis and treatment of male and female androgenetic alopecia.
Recent FDA Clearances: JAK Inhibitors for Alopecia
The FDA has cleared three Janus kinase (JAK) inhibitors for use in the treatment of severe alopecia areata:
Olumiant® (baricitinib) – Approved June 2022, the first-ever systemic treatment for severe alopecia areata for adults.
Litfulo® (ritlecitinib) – Approved June 2023, the first-ever treatment approved for severe alopecia areata in adolescents aged 12+ and adults.
Leqselvi® (deuruxolitinib) – Approved July 2024, in clinical trials, roughly one-third of participants experienced significant regrowth, though outcomes differed across individuals.
Dr. Natasha Mesinkovska, Associate Professor of Dermatology, UC Irvine School of Medicine, stated the following regarding these treatments, “this offers a very promising new option for patients to regrow their hair and change their lives” (UCI Health, 2024).
Regenerative Medicine for Hair Restoration
Platelet-Rich Plasma (PRP) Therapy Results
PRP therapy is considered to be a relatively novel advancement in hair restoration medical management in the past few years. Research has shown that PRP contains concentrated growth factors that stimulate re-initiation of hair follicle growth by increasing angiogenesis and cellular proliferation (Gentile et al., 2015).
Clinical Evidence:
In a randomized study with a placebo control, there were mean increases of 45.9 hairs per cm² for hair density after treatment with Platelet Rich Plasma (PRP) (Gentile et al, 2015).
Their meta-analysis data found that the mean difference in hair density for PRP agents compared to control was 14.38 hairs per cm² (Giordano et al., 2017).
A 2024 systematic review of 21 studies (628 participants) found PRP therapy showed benefits in certain types of female hair loss, though results varied by diagnosis and treatment protocol (Yuan et al, 2024).
Johns Hopkins Medicine, notes that PRP injections may support treatment of male pattern baldness, though effectiveness depends on patient factors and further research is needed (2023).
Stem Cell Therapy Advances
Shiseido’s S-DSC® Therapy: Shiseido has developed a pathway using their dermal sheath cup cells (DSCs); clinical trials were conducted to provide evidence for an effective treatment for male and female pattern baldness at Tokyo Medical University Hospital and Toho University. In July 2024, Shiseido made therapies available to patients in Japan (Recent Advances in Drug Development for Hair Loss, 2024).
Emerging Treatment Protocols
Low-Level Laser Therapy (LLLT): Light devices approved by the FDA with certain wavelengths of light were shown in studies to improve hair density and perceived hair growth compared to other treatments (HairScience, 2024).
Microneedling: Microneedling has been shown to enhance absorption of topical treatments and support natural skin healing, which was associated with hair regrowth when paired with other treatments (Johns Hopkins Medicine, 2023).
Evidence-Based Combination Approaches
There have been indications in studies of the benefits of combined therapy. Based on clinical evidence, studies recommend:
Finasteride with minoxidil to improve outcomes with androgenetic alopecia.
PRP therapy with hair transplant procedures to improve neutrality of follicle survival.
Microneedling with topical treatment for better delivery.
Safety Considerations, Professional Advice
The FDA has communicated with individuals who use other treatment options about following approved products and contacting their medical provider. The FDA advised individuals wanting compounded topical finasteride products should see a qualified healthcare provider (FDA, 2024).
Dr. Maryanne Senna, Director of the Lahey Hair Loss Center of Excellence and Assistant Professor at Harvard Medical School, states “there is a need for further research to determine what is the best practice to obtain the PRP and how to inject it,” and that those considering PRP therapy contact a qualified medical provider (Harvard Health, 2020).
Key Takeaways for Hair Loss Treatment
The field of hair loss treatments continues to make advancements with evidence based treatment methods, providing evidence-based options that healthcare professionals may discuss with patients, as well as looking at FDA approved treatment methods and possible regenerative treatment options. Healthcare providers will talk to patients about their personalized treatment based on individual characteristics, hair loss patterns, and cohorts of treatment methods. While pursuing medical treatments, many men also benefit from learning to camouflage thinning areas with strategic haircuts, and ensuring they get the essential nutrients your hair follicles need for optimal health.
To achieve the best outcome, patients should speak with board-certified dermatologists about the medical evidence of treatment methods for hair loss related to their individual presentations.
Disclaimer
This article is for informational purposes only. It is not medical advice. Always consult a licensed healthcare provider for diagnosis and treatment of hair loss. Individual results vary.
References
American Academy of Dermatology. (2024). Hair loss: Diagnosis and treatment. Retrieved from https://www.aad.org
Cleveland Clinic. (2024, June 30). Hair loss treatments: Topical, medications & surgery options. Cleveland Clinic Health Library. https://my.clevelandclinic.org/health/treatments/8307-hair-loss-treatments
Gentile, P., Garcovich, S., Bielli, A., Scioli, M. G., Orlandi, A., & Cervelli, V. (2015). The effect of platelet-rich plasma in hair regrowth: A randomized placebo-controlled trial. Stem Cells Translational Medicine, 4(11), 1317-1323. https://doi.org/10.5966/sctm.2015-0107
Giordano, S., Romeo, M., & Lankinen, P. (2017). Platelet-rich plasma for androgenetic alopecia: Does it work? Evidence from meta analysis. Journal of Cosmetic Dermatology, 16(3), 374-381.
HairScience. (2024, July 3). Hair loss research: What’s in the pipeline? HairScience Institute. https://hairscience.org/hair-loss-research/
Harvard Health Publishing. (2020, May 11). Platelet-rich plasma: Does the cure for hair loss lie within our blood? Harvard Medical School. https://www.health.harvard.edu/blog/platelet-rich-plasma-does-the-cure-for-hair-loss-lie-within-our-blood-2020051119748
Johns Hopkins Medicine. (2023, June 9). Platelet-rich plasma (PRP) injections. Johns Hopkins Medicine Health Library. https://www.hopkinsmedicine.org/health/treatment-tests-and-therapies/plateletrich-plasma-prp-treatment
National Alopecia Areata Foundation. (2024, July 14). FDA-approved JAK inhibitors. NAAF Treatment Guidelines. https://www.naaf.org/navigation-toolkit/fda-approved-jak-inhibitors/
Pfizer Inc. (2023, June 29). FDA approves Pfizer’s LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata. Pfizer Press Release. https://www.pfizer.com/news/press-release/
Stevens, J., Khetarpal, S., & Gorman, C. (2022). Platelet-rich plasma for androgenetic alopecia: A review of the literature and proposed treatment protocol. International Journal of Women’s Dermatology, 8(1), e007.
UCI Health. (2024, August 2). Newly approved drug offers ‘promising option’ to reverse hair loss. UCI Health News. https://www.ucihealth.org/about-us/news/2024/08/fda-approved-hair-loss-drug
U.S. Food and Drug Administration. (2024). FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products. FDA Drug Safety Communication. https://www.fda.gov/drugs/human-drug-compounding/
Yuan, L., Chen, X., Wang, H., & Zhang, M. (2024). Effectiveness of platelet‐rich plasma in treating female hair loss: A systematic review and meta‐analysis of randomized controlled trials. Skin Research and Technology, 30(8), e13823.
