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ClinicalTrials.gov public records Last synced Oct 30, 2026, 4:45 AM EDT

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Showing 1–24 of 30 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: Oral Leukoplakia Clear all
Completed Not applicable Interventional Results available

A Randomized Study of Sulindac in Oral Premalignant Lesions

NCT00299195
View directory record Official record
Conditions
Leukoplakia, Oral, Benign Neoplasms
Interventions
sulindac, Placebo
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2020
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Nov 19, 2020 · Synced Oct 30, 2026, 4:45 AM EDT
Recruiting Phase 2 Interventional

Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia

NCT05727761
View directory record Official record
Conditions
Oral Leukoplakia
Interventions
pioglitazone-metformin
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years and older
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
2
States / cities
Minneapolis, Minnesota • Saint Paul, Minnesota
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Oct 30, 2026, 4:45 AM EDT
Completed No phase listed Observational

Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making

NCT03239834
View directory record Official record
Conditions
Palatal Neoplasms, Lip Neoplasm, Gingival Neoplasms, Leukoplakia, Oral, Tongue Neoplasms, Oropharyngeal Neoplasms, Oral Ulcer
Interventions
OncAlert
Device
Lead sponsor
Vigilant Biosciences, Inc.
Industry
Eligibility
23 Years and older
Enrollment
893 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2020
U.S. locations
26
States / cities
Beverly Hills, California • La Mesa, California • Loma Linda, California + 22 more
Source: ClinicalTrials.gov public record
Updated Aug 12, 2021 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Phase 2 Interventional Results available

Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia

NCT00099021
View directory record Official record
Conditions
Head and Neck Cancer, Oral Leukoplakia
Interventions
pioglitazone hydrochloride
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2008
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Feb 11, 2022 · Synced Oct 30, 2026, 4:45 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia

NCT05237960
View directory record Official record
Conditions
Erythroplakia, Oral Leukoplakia
Interventions
Biopsy, Biospecimen Collection, Extended Release Metformin Hydrochloride, Placebo Administration
Procedure · Drug
Lead sponsor
University of Arizona
Other
Eligibility
21 Years and older
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
8
States / cities
Tucson, Arizona • San Diego, California • Tampa, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Sep 28, 2026 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Phase 2 Interventional Results available

Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia

NCT00330382
View directory record Official record
Conditions
Lip and Oral Cavity Cancer, Oral Leukoplakia, Oropharyngeal Cancer, Tongue Cancer
Interventions
Bowman-Birk inhibitor concentrate, placebo, laboratory biomarker analysis
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
325 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2013
U.S. locations
1
States / cities
Orange, California
Source: ClinicalTrials.gov public record
Updated Dec 19, 2014 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Phase 1Phase 2 Interventional Results available

Treatment of Oral Premalignant Lesions With 5-ALA PDT

NCT00571974
View directory record Official record
Conditions
Leukoplakia, Erythroplakia
Interventions
PDL-585, ScleroPLUS laser, 5-Aminolevulinic Acid (Levulan KerastickTM), Fluorescence Diagnosis Imaging
Device · Drug · Procedure
Lead sponsor
University of Arkansas
Other
Eligibility
18 Years to 80 Years
Enrollment
29 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2012
U.S. locations
1
States / cities
Little Rock, Arkansas
Source: ClinicalTrials.gov public record
Updated Mar 24, 2015 · Synced Oct 30, 2026, 4:45 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion

NCT02581137
View directory record Official record
Conditions
Erythroplakia, Hyperplasia, Oral Cavity Carcinoma, Oral Leukoplakia
Interventions
Laboratory Biomarker Analysis, Metformin Hydrochloride
Other · Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2026
U.S. locations
2
States / cities
San Diego, California • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Jun 26, 2026 · Synced Oct 30, 2026, 4:45 AM EDT
Withdrawn Phase 1 Interventional

Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia

NCT05505539
View directory record Official record
Conditions
Oral Leukoplakia
Interventions
5-fluorouracil
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Sep 22, 2022 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Phase 2 Interventional

Fenretinide in Treating Patients With Leukoplakia of the Mouth

NCT00004161
View directory record Official record
Conditions
Head and Neck Cancer
Interventions
fenretinide, Placebo
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1997 – 2004
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Apr 12, 2013 · Synced Oct 30, 2026, 4:45 AM EDT
Recruiting No phase listed Observational

Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™

NCT05853783
View directory record Official record
Conditions
Mouth Diseases
Interventions
STRATICYTE™ Test
Other
Lead sponsor
Proteocyte Diagnostics Inc.
Industry
Eligibility
18 Years and older
Enrollment
180 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
5
States / cities
Birmingham, Alabama • Loma Linda, California • Minneapolis, Minnesota + 1 more
Source: ClinicalTrials.gov public record
Updated Nov 7, 2024 · Synced Oct 30, 2026, 4:45 AM EDT
Terminated Phase 2 Interventional Results available

Pioglitazone for Oral Premalignant Lesions

NCT00951379
View directory record Official record
Conditions
Oral Leukoplakia
Interventions
Pioglitazone hydrochloride, placebo, laboratory biomarker analysis
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
11
States / cities
Birmingham, Alabama • Iowa City, Iowa • Boston, Massachusetts + 6 more
Source: ClinicalTrials.gov public record
Updated Apr 6, 2016 · Synced Oct 30, 2026, 4:45 AM EDT
Terminated Phase 1 Interventional

Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

NCT00571558
View directory record Official record
Conditions
Oral Leukoplakia
Interventions
aminolevulinic acid hydrochloride, photodynamic therapy, laboratory biomarker analysis
Drug · Other
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
4
States / cities
Chicago, Illinois • Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Oct 9, 2014 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Not applicable Interventional

Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)

NCT00002026
View directory record Official record
Conditions
Leukoplakia, Hairy, HIV Infections
Interventions
Acyclovir
Drug
Lead sponsor
Glaxo Wellcome
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jun 24, 2005 · Synced Oct 30, 2026, 4:45 AM EDT
Terminated Phase 1 Interventional

Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions

NCT05536037
View directory record Official record
Conditions
Erythroplakia, Leukoplakia, Oral Cavity Carcinoma, Proliferative Verrucous Leukoplakia
Interventions
Metformin, Biopsy
Drug · Procedure
Lead sponsor
Thomas Jefferson University
Other
Eligibility
18 Years to 85 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 15, 2025 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Phase 2 Interventional Results available

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract

NCT00453336
View directory record Official record
Conditions
Head and Neck Cancer, Precancerous/Nonmalignant Condition
Interventions
Porfimer Sodium, Photodynamic Therapy
Drug · Procedure
Lead sponsor
University of Miami
Other
Eligibility
18 Years to 120 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2010
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Feb 8, 2017 · Synced Oct 30, 2026, 4:45 AM EDT
Active, not recruiting Not applicable Interventional

Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer

NCT00542373
View directory record Official record
Conditions
Erythroplakia, Fanconi Anemia, Lichen Planus, Oral Cavity and Lip Precancerous Condition, Oral Cavity Leukoplakia, Oral Neoplasm, Premalignant Lesion, Tobacco Use Disorder
Interventions
Cytology Specimen Collection Procedure, Diagnostic Microscopy, Diagnostic Procedure, Fluorescence Imaging, Fluorescence Spectroscopy
Other · Procedure
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
338 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2027
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 14, 2026 · Synced Oct 30, 2026, 4:45 AM EDT
Withdrawn Phase 1 Interventional

This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions

NCT03939364
View directory record Official record
Conditions
Leukoplakia, Oral
Interventions
SBS-101, Placebo
Drug
Lead sponsor
Skyline Biosciences
Industry
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
5
States / cities
Birmingham, Alabama • Boston, Massachusetts • Charlotte, North Carolina + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 19, 2021 · Synced Oct 30, 2026, 4:45 AM EDT
Completed No phase listed Observational

Biomarkers for Oral Cancer

NCT00341497
View directory record Official record
Conditions
Lichen Planus, Oral Leukoplakia, Mouth Neoplasms
Interventions
Not listed
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 110 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1996 – 2025
U.S. locations
6
States / cities
San Francisco, California • Washington D.C., District of Columbia • Atlanta, Georgia + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 31, 2025 · Synced Oct 30, 2026, 4:45 AM EDT
Recruiting Phase 1Phase 2 Interventional

Topical Imiquimod Treatment of Oral Dysplasia

NCT07210775
View directory record Official record
Conditions
Oral Dysplasia, Leukoplakia Oral, Leukoplakia
Interventions
Imiquimod (topical use)
Drug
Lead sponsor
University of Southern California
Other
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Mar 4, 2026 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia

NCT03692325
View directory record Official record
Conditions
Leukoplakia, Oral
Interventions
Nivolumab
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 1, 2024 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Not applicable Interventional

Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)

NCT00002043
View directory record Official record
Conditions
Pneumonia, Pneumocystis Carinii, HIV Infections
Interventions
Dapsone
Drug
Lead sponsor
Jacobus Pharmaceutical
Industry
Eligibility
12 Years and older
Healthy volunteers
Healthy volunteers not accepted
U.S. locations
1
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Jun 24, 2005 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Phase 2 Interventional

Randomized, Double Blind, Placebo-Controlled, Phase IIB Trial of Ketorolac Mouth Rinse Evaluating the Effect of Cyclooxygenase Inhibition on Oropharyngeal Leukoplakia: Collaborative Study of the NCI, NIDCD and the NIDCR

NCT00001698
View directory record Official record
Conditions
Leukoplakia, Periodontal Disease
Interventions
Ketorolac Rinse
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
Not listed
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1998 – 2004
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 4, 2008 · Synced Oct 30, 2026, 4:45 AM EDT
Completed Phase 1 Interventional

Fenretinide Mucoadhesive Patch: Evaluation of Oral Cancer Prevention Efficacy in Adults With Premalignant Oral Lesions.

NCT07149220
View directory record Official record
Conditions
Oral Leukoplakia, Oral Dysplasia
Interventions
Mucoadhesive fenretinide-releasing system (FMS)
Drug
Lead sponsor
Ohio State University Comprehensive Cancer Center
Other
Eligibility
18 Years to 100 Years
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Sep 25, 2026 · Synced Oct 30, 2026, 4:45 AM EDT