Adjunctive Use of VGH4 for Moderate-to-Severe Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Trial

Moderate-to-severe atopic dermatitis (AD) requires safe, long-term management strategies to complement conventional pharmacotherapy. This study evaluated the efficacy and safety of VGH4, a standardized multi-herb traditional Chinese medicine (TCM) formula, as an adjunct to standard care. In a randomized, double-blind, placebo-controlled crossover pilot trial, 19 patients with moderate-to-severe AD (SCOring Atopic Dermatitis Index (SCORAD) ≥ 25) received VGH4 or placebo for 6 weeks, separated by a 2-week washout. Primary outcomes assessed disease severity (SCORAD), while secondary outcomes included quality of life (DLQI/CDLQI) and safety. Eighteen patients completed the study. VGH4 yielded a median within-patient SCORAD reduction 10.2 points greater than placebo (p = 0.054). The primary endpoint did not reach statistical significance at the α = 0.05 level (p = 0.054); nevertheless, the observed magnitude of improvement exceeded the established minimal clinically important differences (MCIDs). The subjective SCORAD component showed a significant between-treatment difference favoring VGH4 (p = 0.015), and a statistically significant improvement in quality of life was also observed in adult patients (p = 0.023). In conclusion, VGH4 was generally well tolerated in this short-term pilot trial, with no serious adverse events, and showed preliminary signals of possible benefits in patient-reported outcomes as an adjunct therapy. These exploratory findings warrant confirmation in larger, adequately powered trials.