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This Phase 1/Phase 2 study evaluates a bioadhesive gel containing 10% black raspberry (FBR), compared with placebo gel, for the prevention of oral cancer in people with precancerous mouth lesions. It included people aged 21-80 with microscopically confirmed premalignant oral changes who were tobacco-free. It was carried out in Phase 1/Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Ages: 21 to 80 2. Microscopically confirmed premalignant oral epithelial disease 3. No previous history of cancer (with the exception of basal cell carcinoma of the skin) 4. Tobacco free for at least six weeks prior to entrance in the trial and remain tobacco-free for the three month duration of the study 5. Availability for necessary study follow-up evaluations (every 10 to 14 days during the trial) 6. Capable of providing informed consent. Exclusion Criteria: 1. Previous history of cancer (with the exception of basal cell carcinoma of the skin) 2. Current use of tobacco products or refusal to remain tobacco-free for the three month duration of the study 3. Lack of microscopically confirmed premalignant oral epithelial changes 4. Microscopic diagnosis of oral squamous cell carcinoma 5. Previous history of radiation therapy on same side of the head and neck region 6. History of allergy to any kind of berry 7. Women who are determined to be pregnant or plan to be pregnant during the trial 8. Women who are nursing.