ArticleDermatology and therapy2026
Safety, Pharmacokinetics, and Efficacy of 1.5% Ruxolitinib Gel (HDM3010) in Adult Patients with Prurigo Nodularis: A Phase I/II, Randomized, Double-Blind, Vehicle-Controlled Multicenter Clinical Trial.
Article in Dermatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionPrurigo nodularis (PN) is a chronic inflammatory dermatosis with severe, persistent pruritus and limited effective therapies. Janus kinase (JAK) inhibition has emerged as a targeted strategy for PN.
methodsThis phase I/II, randomized, double-blind, vehicle-controlled, multicenter clinical trial was conducted in China to evaluate the safety, pharmacokinetics, and efficacy of topical 1.5% ruxolitinib gel (HDM3010) in adults with PN. Adult patients with PN were randomized 2:1 to receive HDM3010 or vehicle, administered once daily (QD) or twice daily (BID), during a 4-week double-blind treatment period.
resultsForty-nine patients were randomized. HDM3010 demonstrated a safety profile characterized by treatment-emergent adverse events in 18.8% of QD and 25.0% of BID patients, compared with 12.5% of vehicle QD and 55.6% of vehicle BID patients. Treatment-related adverse events were infrequent (4.1%) and limited to mild-to-moderate severity. Pharmacokinetic analyses showed low systemic exposure, with mean peak plasma concentrations below 7 ng/mL at steady state. Compared with vehicle, HDM3010 was associated with higher proportions of ≥ 4-point Worst Itch Numerical Rating Scale (WI-NRS) responders and greater improvements in WI-NRS, Investigator's Global Assessment for Prurigo Nodularis-Stage (IGA PN-S), and Investigator's Global Assessment for Prurigo Nodularis-Activity (IGA PN-A) scores.
conclusionsHDM3010 demonstrated a favorable safety profile, minimal systemic exposure, and positive trends in reducing pruritus and lesions in adults with PN.
trial registrationChinese Clinical Trial Registry ( http://www.chictr.org.cn ): ChiCTR2500096434 (registered January 23, 2025).
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