Ruxolitinib cream monotherapy for facial and/or neck atopic dermatitis: results from a decentralized, randomized phase 2 clinical trial.

Abstract

Purpose: Ruxolitinib cream was evaluated in patients with facial/neck atopic dermatitis (AD) in a decentralized, double-blind, randomized clinical trial (NCT05127421).

Materials and methods: Patients aged 12-70 years with AD (Investigator's Global Assessment [IGA] score 2/3, ≤20% affected body surface area [face/neck, ≥0.5%]) were randomized 2:1 to twice-daily 1.5% ruxolitinib cream or vehicle for 4 weeks; thereafter, all patients applied as-needed ruxolitinib cream for 4 additional weeks. The primary endpoint was ≥75% improvement in head/neck Eczema Area and Severity Index (EASI-75) at Week 4 assessed by blinded central reader using photographs.

Results: Among 77 randomized patients (median [range] age, 38.0 [17-66] y), 44.2% were Black. The mean (SD) baseline head/neck EASI was 1.2 (0.7). More patients who applied ruxolitinib cream vs vehicle achieved head/neck EASI-75 at Week 4 (37.0% vs 17.4%; p = 0.091). Improvements with ruxolitinib cream vs vehicle were observed for facial/neck IGA treatment success (IGA 0/1 with ≥2-point improvement from baseline) and Patient-Oriented Eczema Measure (overall and itch). Ruxolitinib cream was well tolerated, including on the face and neck. Application site reactions were infrequent (ruxolitinib cream, 1.9% [n = 1]; vehicle, 8.7% [n = 2]).

Conclusions: Ruxolitinib cream improved signs and symptoms of facial/neck AD vs vehicle and was well tolerated.