Vitamin A loaded Bioadhesive Patches for Oral Mucosal Delivery in Treatment of Potentially Malignant White Lesions: A Placebo-Controlled Study

Abstract

Introduction: This randomized controlled trial aimed to evaluate the efficacy of Vitamin Aloaded bioadhesive patches for the treatment of potentially malignant white lesions of the oral mucosa.
Materials and Methods: A total of 100 participants with clinically diagnosed oral leukoplakia were randomly assigned to receive either Vitamin A-loaded bioadhesive patches (n=50) or placebo patches (n=50) for 8 weeks. The primary outcome was the reduction in lesion size, while secondary outcomes included histopathological improvement, patient-reported pain levels, and adverse effects. Participants were followed up for 36 months to assess long-term efficacy and lesion recurrence.
Results: At the end of the treatment period, the intervention group showed a significantly greater reduction in lesion size (mean 18.6 mm²) compared to the control group (mean 7.4 mm²) (p < 0.001). Histopathological improvement was observed in 70% of participants in the intervention group versus 30% in the control group (p < 0.001). Long-term follow-up revealed that 78% of participants in the intervention group remained lesion-free at 36 months, with no cases of malignant transformation, compared to 46% in the control group (p < 0.01).
Conclusion: Vitamin A-loaded bioadhesive patches are an effective and safe treatment for potentially malignant white lesions, offering significant lesion size reduction, histopathological improvement, and sustained long-term benefits with minimal adverse effects. This study supports the use of localized Vitamin A therapy as a promising approach for the management of oral potentially malignant disorders.