Nanostructured Ayurvedic Emulsion of Bakuchiol & Neem Oil for Mild‑to‑Moderate Alopecia Areata Open‑Label Single‑Arm Pilot Study

Alopecia Areata (AA) is a chronic autoimmune condition characterized by patchy, non-scarring hair loss, for which current therapeutic options—such as corticosteroids, immunosuppressants, and JAK inhibitors—offer inconsistent long-term results and may involve significant side effects. Natural alternatives with immunemodulatory and follicular regenerative potential are gaining attention, especially when combined with modern delivery systems. In this pilot study, a novel nanoemulsion containing Bakuchiol (1%) and Neem oil (3%) with an average droplet size of ~100 nm was evaluated for safety and efficacy in AA. Thirty adult participants (aged 18–45 years) applied the formulation topically on the affected scalp areas twice daily for 12 weeks. Efficacy was assessed using phototrichogram for hair density, Severity of Alopecia Tool (SALT) score, Visual Analogue Scale (VAS) for patient satisfaction, dermoscopy for scalp changes, and general safety evaluations. By the end of the treatment period, a statistically significant increase in hair density (~25%, p < 0.001) and a reduction in SALT score (~33%, p < 0.001) were observed, indicating clinical improvement in hair regrowth. Dermoscopic observations supported these findings, showing an increase in terminal hair count and reduction in dystrophic signs such as exclamation mark hairs and black dots. Patient satisfaction was high, with 85% rating their outcome as “good” or “very good” on the VAS. The formulation was well-tolerated, with only mild transient scalp tingling reported in 10% of participants and no serious adverse effects. The nanoemulsion’s enhanced delivery likely contributed to improved penetration and efficacy of the herbal actives. These results suggest that combining traditional Ayurvedic ingredients with nanotechnology offers a promising and well-tolerated alternative for AA management. Further randomized, controlled trials with larger populations are recommended to validate these preliminary outcomes