Beyond Regrowth: Progress and Open Questions in Alopecia Areata Research

Alopecia areata treatment has advanced faster than the tools used to measure it. Here is what sponsors should consider when designing the next generation of alopecia areata studies.

September is Alopecia Areata Awareness Month, an opportunity to build understanding of an autoimmune disease that approximately 2% of people worldwide will experience during their lifetime.^1,2 Alopecia areata can affect both appearance and emotional well-being. As treatment options expand, awareness can help bring attention to the experiences of people living with alopecia areata and the research still needed to improve their care.^3,4

An Unpredictable Disease Is a Hard Disease to Study

Alopecia areata develops when the immune system mistakenly attacks hair follicles, causing hair loss. It is not contagious, and it is a non-scarring form of hair loss, which is why regrowth remains possible. It often begins as round or oval patches on the scalp, but it can also affect the eyebrows, eyelashes, and other areas of the body. In more extensive forms, people may lose most or all scalp hair, known as alopecia totalis, or hair across the scalp and body, known as alopecia universalis.^3,5

The condition can begin at any age, and its course is difficult to predict. Hair may regrow, fall out again, or remain absent for an extended period. This uncertainty can add to the challenges of living with visible hair loss.^3,4 For sponsors, that unpredictability shapes trial design: spontaneous regrowth and relapse both occur, so control arms, visit frequency, and follow-up duration have to be long enough to tell treatment effect from the natural course of the disease.

The Burden Patients Carry Follows Them Into the Trial

The effects of alopecia areata can reach into everyday life. Changes in appearance may affect confidence and emotional well-being, and anxiety and depression are more common among people with the condition.^4,5 In a large UK population study, people with alopecia areata were also more likely to be issued medical certificates for time off work and to be recorded as unemployed, a reminder that the burden extends well beyond appearance.⁵ Support from healthcare professionals and others with similar experiences can help people manage these challenges.⁴

People also have different priorities. Some pursue treatment to encourage regrowth, while others choose to live with hair loss or use wigs and other coverings. Respecting those choices is an essential part of supportive care.⁴ Trial participants, by definition, are drawn only from those who chose to pursue treatment, which is one reason patient-reported outcomes and expectations at baseline deserve as much attention as clinical measures.

Approved Therapies Answered One Question and Raised Others

Oral Janus kinase, or JAK, inhibitors have expanded treatment options for severe alopecia areata. FDA-approved options include baricitinib (Olumiant) and deuruxolitinib (Leqselvi) for adults, and ritlecitinib (Litfulo) for adults and adolescents aged 12 years and older. These medicines act on immune signaling involved in the disease.^6–9 Additional treatment options are emerging. In July 2026, the European Commission approved upadacitinib (Rinvoq) for adults and adolescents aged 12 years and older with severe alopecia areata. At the time of the July announcement, an application for the same use was under FDA review in the United States.^10,11

Treatment response varies, and there is currently no cure. For many people these are ongoing therapies rather than a fixed course: in a randomized withdrawal study of baricitinib, most patients who stopped treatment after regrowth lost that benefit over time, although most who restarted treatment regained their response during follow-up.¹² These medicines also carry important risks, including boxed warnings for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, and require individualized assessment and monitoring.^7–9 Continued research is needed to help more people achieve meaningful, sustained improvement with an acceptable safety profile.

The Endpoint Measures the Scalp; Patients Measure More

Clinical trials provide the evidence needed to evaluate potential treatments and guide care. In the pivotal trials of the approved therapies, the primary efficacy endpoint has been a Severity of Alopecia Tool (SALT) score of 20 or less, meaning at least 80% scalp hair coverage, assessed at week 24 or week 36.^7–9 That endpoint matters, but SALT measures the scalp only. For many patients, eyebrow and eyelash regrowth can also be important, along with how long improvement lasts and how treatment affects daily life. Listening to patients can help researchers understand which outcomes matter most to them.

SALT is also a visual estimate made by a trained rater, making consistent assessment at the site important for data quality.¹³ Rater training, consistent assessors across visits where feasible, and standardized photography all help. Important questions also remain open, including treatment for children under 12, options for people with less extensive disease, and how to sustain results over the long term. Each of those open questions is a study still to be designed.

Research sites play an important role in that process. With clear explanations of study requirements, consistent follow-up, and respectful communication, they can support participants throughout a trial. That includes practical details: studies that run for six months to a year or longer ask a lot of participants, and visits may involve photography and removing wigs or head coverings, which calls for privacy and sensitivity. Because alopecia areata affects people of all ages, genders, and racial and ethnic groups,² making participation practical for people with different backgrounds and circumstances should remain a priority. Sponsors that plan for these realities at the protocol stage, rather than at the first retention problem, tend to see it reflected in enrollment and data quality.

Why Now

Three JAK inhibitors are approved, a fourth is under FDA review, and the pipeline behind them is competing for the same experienced dermatology sites and the same patients, many of whom have already enrolled in an earlier study. As that competition intensifies, capable networks fill their capacity. Sponsors who engage a specialized network early, while planning the program rather than after enrollment stalls, protect their timelines.

Conclusion

Alopecia areata now has effective therapies. The next generation of studies will be judged on whether they can measure what patients value, hold on to participants for long enough to show durability, and reflect the full range of people who live with the condition. Sponsors planning alopecia areata studies and investigators interested in joining our network are welcome to contact us at rich@precefi.com or visit precefi.com to learn more.

References

1. National Alopecia Areata Foundation. Alopecia Areata Awareness Month.
2. National Alopecia Areata Foundation. Alopecia Areata.
3. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Alopecia Areata.
4. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Alopecia Areata Diagnosis Treatment and Steps to Take.
5. Macbeth AE, Holmes S, Harries M, et al. The associated burden of mental health conditions in alopecia areata: a population-based study in UK primary care. Br J Dermatol. 2022;187(1):73-81.
6. National Alopecia Areata Foundation. FDA Approved JAK Inhibitors.
7. US Food and Drug Administration. FDA Approves First Systemic Treatment for Alopecia Areata. June 13, 2022.
8. US Food and Drug Administration. LITFULO Prescribing Information. 2023.
9. US Food and Drug Administration. Drug Trials Snapshots LEQSELVI.
10. AbbVie. European Commission Approval of RINVOQ (upadacitinib) for the Treatment of Adults and Adolescents with Severe Alopecia Areata. July 29, 2026.
11. AbbVie. AbbVie Submits Application to FDA for Upadacitinib (RINVOQ) for Adults and Adolescents with Severe Alopecia Areata. April 28, 2026.
12. King B, Ko J, Kwon O, et al. Baricitinib withdrawal and retreatment in patients with severe alopecia areata: the BRAVE-AA1 randomized clinical trial. JAMA Dermatol. 2024;160(10):1075-1081.
13. Atanaskova Mesinkovska N, King BA, Vañó-Galván S, et al. Visualizing Severity of Alopecia Tool (SALT) scores in the clinical setting using patient images from a clinical trial. JEADV Clin Pract. 2024;3(2):528-535.

Sources accessed September 21, 2026.