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Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

NCT01192204 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2015-08-14

Study results available
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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

  • Squamous Cell Carcinoma of Mouth
  • Intraepithelial Neoplasia

Interventions

DRUG

10% FBR containing bioadhesive gel

0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

DRUG

placebo gel

0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Sponsors & Collaborators

  • University of Louisville

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ohio State University

    lead OTHER

Principal Investigators

  • Susan R Mallery, DDS, PhD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01192204 on ClinicalTrials.gov