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Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
NCT01192204 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG placebo gel
- DRUG 10% FBR containing bioadhesive gel
Study Locations (3)
Kentucky
- University of Louisville, School of Dentistry — Louisville
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
Ohio
- The Ohio State University, College of Dentistry — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2010-10 |
| Est. Completion | 2014-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01192204
The ClinicalTrials.gov registry entry for NCT01192204 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 640 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Intraepithelial Neoplasia appearing as the primary indexed condition, and to 2 interventions — of which placebo gel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01192204 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Kentucky, North Carolina, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01192204 about?
NCT01192204 is a clinical study titled "Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention". 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...
What is the current status of trial NCT01192204?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2010-10. Estimated completion is 2014-02.
What conditions does trial NCT01192204 study?
This clinical trial studies the following conditions: Intraepithelial Neoplasia, Squamous Cell Carcinoma of Mouth. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01192204?
The interventions under investigation include: placebo gel (DRUG), 10% FBR containing bioadhesive gel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01192204?
This trial is sponsored by Ohio State University, which has 640 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01192204 being conducted?
This trial has 3 study locations across Kentucky, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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