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Study aim
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This study evaluates the safety and efficacy of a novel mouthwash containing cyclosporine, dexamethasone, and nystatin in patients with oral cGvHD. The formulation may improve oral lesions, reduce symptoms, enhance quality of life, and prevent fungal infections.
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Design
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The present clinical trial is a single group, phase 3, that will be conducted on 20 patients.
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Settings and conduct
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This study is conducted at the Oncology, Hematology, and Cell Therapy Research Center located at Shariati Hospital. Twenty patients are enrolled in the study, and their conditions are monitored and evaluated over six consecutive weeks.
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Participants/Inclusion and exclusion criteria
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Exclusion criteria:
Patients with hypersensitivity to any formulation component (cyclosporine, dexamethasone, or nystatin); concurrent systemic tacrolimus use; active acute oral bacterial, viral, or fungal infection; pregnancy or breastfeeding; acute adverse events requiring discontinuation of calcineurin inhibitors; poor cooperation during follow-up; non-compliance with proper mouthwash use or storage (e.g., incorrect dosing, discontinuation, or swallowing after topical use); or use of topical oral corticosteroids within the past 12 weeks.
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Intervention groups
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Age over 18 years
History of hematopoietic stem cell transplantation (HSCT) more than 100 days prior
Evidence of chronic GvHD
Clinically symptomatic erosive and ulcerative cGvHD as confirmed by the treating physician
Inadequate response to initial systemic therapy (corticosteroid or calcineurin inhibitor) within the past 4 weeks
Patient’s informed consent to participate in the study
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Main outcome variables
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Improvement of oral lesions caused by chronic mucosal GvHD