Oral Nintedanib for Refractory Generalized Keloids: A Prospective Exploratory Pilot Study

ABSTRACT Background Generalized keloids are severe, treatment‐refractory, disfiguring dermatoses that substantially impair physical and psychosocial well‐being and have limited effective systemic treatment options. Objective To assess the short‐term safety, tolerability, and exploratory clinical outcomes of oral nintedanib in patients with refractory generalized keloids. Methods In this single‐center, open‐label, assessor‐blinded exploratory pilot study, 10 adults with refractory generalized keloids received oral nintedanib 150 mg once daily or 150 mg twice daily for 8 weeks. The primary exploratory endpoint was change in Vancouver scar scale (VSS) score from baseline to Week 8. Secondary endpoints included pruritus and pain visual analogue scale (VAS) scores, patient and observer scar assessment scale (POSAS), dermatology life quality index (DLQI), imaging and histological assessments, and safety outcomes. Results All participants completed treatment and follow‐up. Mean VSS scores decreased from 11.2 ± 1.3 to 8.2 ± 1.1 in the low‐dose group and from 10.4 ± 1.8 to 8.2 ± 1.9 in the high‐dose group. Pruritus severity and visible scar vascularity showed numerical improvements over 8 weeks, whereas POSAS and DLQI changed little. Histological assessment suggested reduced cellularity and more organized collagen architecture after treatment. No serious adverse events or treatment discontinuations occurred; the most common treatment‐related adverse events were mild diarrhea and transient transaminase elevation. Conclusion In this small, uncontrolled exploratory pilot study, oral nintedanib was associated with early favorable changes in selected clinician‐rated and symptom‐based outcomes, whereas POSAS and DLQI showed limited short‐term change. These findings are preliminary and hypothesis‐generating and warrant confirmation in larger controlled studies with longer treatment and follow‐up.