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Dexamethasone + nystatin is a topical oral rinse formulation developed for the management of symptomatic oral lesions associated with chronic graft-versus-host disease (cGVHD). The formulation contains dexamethasone (0.1 mg/mL), a potent synthetic corticosteroid that acts as an anti-inflammatory and immunosuppressive agent by targeting the glucocorticoid receptor, and nystatin (100,000 UI/mL), a polyene antifungal used to prevent secondary oral candidiasis, a common complication of local steroid therapy. This combination was evaluated in a Phase 3 randomized, double-blind clinical trial (NCT01444898) led by the Grupo de Estudos Multicentricos em Onco-Hematologia (GEMOH) and investigators from the Universidade Federal do Rio de Janeiro, where it was compared against clobetasol propionate rinses in hematopoietic stem cell transplant recipients.
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