At a glance
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Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
In Brief
A Phase 2 clinical trial evaluating 10% FBR containing bioadhesive gel and placebo gel for Squamous Cell Carcinoma of Mouth and Intraepithelial Neoplasia. Completed, enrolled 41 participants across 3 sites.
Detailed Summary
This is a multicenter placebo-controlled clinical trial to assess the effects of a topically applied gel on precancerous oral epithelial lesions. A total of 41 participants will be enrolled in this trial, and 22 of them will be enrolled at Ohio State. \[The remaining 19 participants will be enrolled at the University of North Carolina (9 participants) and the University of Louisville (8 participants)\]. At all three institutions, half of the participants will randomly be assigned to the 10% FBR gel (0.5 gm four times daily for 3 months), while half will enter the placebo control arm. All trial participants will have a pretreatment (including lesional and perilesional tissue) biopsy taken before and an excisional biopsy after 3 months of treatment. As pretreatment indices are compared to post treatment effects on each patient, patients serve as their own internal control. Pretreatment lesional biopsies are obtained to establish a pretreatment diagnosis and provide a pretreatment baseline for the experimental parameters.
Study Details
Timeline
Interventions
0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months