Comparative study of safety and efficacy of tofacitinib (2%) and minoxidil (2%) in childhood patchy alopecia areata

Objectives: Alopecia areata (AA) is a common autoimmune condition causing non-scarring hair loss, with nearly one-fifth of cases manifesting in children. Management of pediatric AA remains a therapeutic challenge as many systemic immunosuppressants have safety concerns in this age group. Minoxidil, a vasodilator, has long been established as a topical treatment, whereas tofacitinib, a Janus kinase (JAK) inhibitor, has recently emerged as a potential therapeutic option. While oral tofacitinib has demonstrated efficacy, systemic adverse effects limit its use in children. Topical tofacitinib may bypass systemic toxicity while retaining efficacy, though data in pediatric AA are sparse. The present study aimed to compare the safety and efficacy of topical tofacitinib 2% ointment with topical minoxidil 2% solution in childhood patchy AA. Material and Methods: This randomized, single-blinded, single-center clinical trial was conducted at the Skin and Venereology Department of Deep Chand Bandhu Hospital, New Delhi, between November 2024 and May 2025. A total of 82 pediatric patients aged 5–14 years, with AA of less than one year’s duration, were enrolled after ethical clearance and informed consent. Patients with poor prognostic subtypes (alopecia totalis, universalis, ophiasis, sparse irregular small alopecic patches with hair preservation in the occipital area [SISAIPHO]) and those with disease duration exceeding one year were excluded. Participants were randomized into Group A (tofacitinib 2% ointment, n = 41) and Group B (minoxidil 2% solution, n = 41). Both agents were applied twice daily for 16 weeks. Diagnosis of AA was confirmed by clinical and trichoscopic features. Efficacy was assessed using Severity of Alopecia Tool (SALT) scores, measured at baseline and follow-up visits (weeks 4, 8, 12, 16). Regrowth score (RGS), reflecting percentage change in SALT score, was calculated at each follow-up. Statistical analyses included Welch’s t-test for continuous variables and chi-square test for categorical variables, with p < 0.05 considered significant. Adverse events were recorded at each visit. Results: Out of 82 patients enrolled, 78 completed the trial (38 in Group A, 40 in Group B). The baseline demographics, including age, sex, disease duration, and number of lesions, were comparable between groups ( p > 0.05). The mean baseline SALT scores were 25.8 ± 9.18 in Group A and 28.8 ± 10.24 in Group B ( p = 0.170), indicating no significant baseline severity difference. Both groups demonstrated progressive improvement in SALT scores across follow-up visits. During the 12th and 16 weeks, Group A exhibited significantly greater reduction in SALT scores compared to Group B ( p = 0.024 and p = 0.040, respectively). At week 16, the mean percentage improvement in SALT score was 82.55 ± 5.60 in Group A versus 76.38 ± 6.85 in Group B ( p < 0.001). RGS analysis showed both groups achieved highly effective responses (RGS = 4), but more patients in the tofacitinib group attained higher RGS categories compared to minoxidil ( p < 0.05). Adverse effects were mild in both groups. Tofacitinib recipients experienced folliculitis ( n = 2) and irritation ( n = 3), while minoxidil recipients developed pruritus ( n = 4) and mild eczema ( n = 3). No systemic adverse effects were noted. None required discontinuation of therapy. Limitations: Short follow up limits the scope of inferences over remission and/or relapse after discontinuation of the said agents. Conclusion: This random comparative study demonstrates that both topical tofacitinib 2% ointment and minoxidil 2% solution are safe and highly effective in treating childhood patchy AA. Topical tofacitinib showed a slightly superior efficacy profile, with statistically significant improvement in SALT scores and RGS compared to minoxidil, and a comparable safety profile. Given the systemic toxicity concerns of oral JAK inhibitors, topical tofacitinib represents a promising, well-tolerated alternative in the pediatric population above 5 years of age. Larger multicentric studies with longer follow-up are warranted to confirm the durability of remission and long-term safety.