8 completed, 4 recruiting, 3 active not recruiting, 2 terminated. 19 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Completed 8, Recruiting 4, Active not recruiting 3, Terminated 2, Not yet recruiting 1, Unknown 1 |
| Phase 1 | 2 | Completed 1, Recruiting 1 |
| Phase 3 | 1 | Active not recruiting 1 |
Follow Leukoplakia: new trials by email Literature Review of Leukoplakia trials Research Report on Leukoplakia
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Low-cost Screening and Image-guided Photodynamic Therapy (PDT) of Premalignant and Malignant Oral Lesions 5-Amino Levulinic Acid - Oral Cancer, Oral Cavity Cancer | Phase 2 | Not yet recruiting | University of Massachusetts, Boston | 65 | 2026-09-01 | 2026-03-19 |
| Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia Metformin Hydrochloride, Placebo - Oral Leukoplakia | Phase 2 | Recruiting | Cairo University | 34 | 2026-02-01 | 2026-02-06 |
| Topical Imiquimod Treatment of Oral Dysplasia Imiquimod (topical use) - Oral Dysplasia, Leukoplakia Oral | Phase 1 / Phase 2 | Recruiting | University of Southern California | 20 | 2025-10-01 | 2026-03-04 |
| Topical Calcipotriol Versus Photodynamic Therapy in the Treatment of Oral Leukoplakia Calcipotriol 0.005% gel, ALA mediated PDT - Oral Leukoplakia | Phase 2 / Phase 3 | Active not recruiting | Alexandria University | 30 | 2025-07-16 | 2026-06-22 |
| Pioglitazone-Metformin Combination Treatment for High Risk Oral Preneoplasia pioglitazone-metformin - Oral Leukoplakia | Phase 2 | Recruiting | University of Minnesota | 36 | 2025-01-01 | 2026-07-29 |
| Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia Biopsy, Biospecimen Collection, Extended Release Metformin Hydrochloride - Erythroplakia, Oral Leukoplakia | Phase 2 | Active not recruiting | University of Arizona | 34 | 2023-01-12 | 2026-09-28 |
| Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - Phase 2 Clinical Trial Metil 5-aminolevulinate - Actinic Cheilitis, Leukoplakia | Phase 2 | Unknown | Instituto Nacional de Cancer, Brazil | 40 | 2019-10-17 | 2019-06-19 |
| Pembrolizumab in Treating Participants With Leukoplakia Pembrolizumab - Erythroleukoplakia, Leukoplakia | Phase 2 | Recruiting | Jonsson Comprehensive Cancer Center | 26 | 2019-05-03 | 2026-08-20 |
| Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia Nivolumab - Leukoplakia, Oral | Phase 2 | Completed | Dana-Farber Cancer Institute | 33 | 2018-12-05 | 2024-10-01 |
| Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion Laboratory Biomarker Analysis, Metformin Hydrochloride - Erythroplakia, Hyperplasia | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 26 | 2016-06-10 | 2026-06-26 |
| Pioglitazone for Oral Premalignant Lesions Pioglitazone hydrochloride, placebo, laboratory biomarker analysis - Oral Leukoplakia | Phase 2 | Terminated | National Cancer Institute (NCI) | 52 | 2010-02-01 | 2016-04-06 |
| Treatment of Oral Premalignant Lesions With 5-ALA PDT PDL-585, ScleroPLUS laser, 5-Aminolevulinic Acid (Levulan KerastickTM), Fluorescence Diagnosis Imaging - Leukoplakia, Erythroplakia | Phase 1 / Phase 2 | Completed | University of Arkansas | 29 | 2007-01-01 | 2015-03-24 |
| Rosiglitazone Maleate in Treating Patients With Oral Leukoplakia rosiglitazone maleate, laboratory biomarker analysis - Oral Leukoplakia | Phase 2 | Completed | National Cancer Institute (NCI) | 25 | 2006-06-01 | 2013-02-13 |
| Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia celecoxib - Head and Neck Cancer, Precancerous Condition | Phase 2 | Completed | Fox Chase Cancer Center | 2003-11-01 | 2013-07-11 | |
| A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia Lozenge Intake - Oral Leukoplakia | Phase 2 | Terminated | University of Medicine and Dentistry of New Jersey | 8 | 2003-09-01 | 2009-12-11 |
| Pioglitazone Hydrochloride in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia pioglitazone hydrochloride - Head and Neck Cancer, Oral Leukoplakia | Phase 2 | Completed | National Cancer Institute (NCI) | 21 | 2003-06-01 | 2022-02-11 |
| Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract Porfimer Sodium, Photodynamic Therapy - Head and Neck Cancer, Precancerous/Nonmalignant Condition | Phase 2 | Completed | University of Miami | 45 | 2003-06-01 | 2017-02-08 |
| Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia Bowman-Birk inhibitor concentrate, placebo, laboratory biomarker analysis - Lip and Oral Cavity Cancer, Oral Leukoplakia | Phase 2 | Completed | National Cancer Institute (NCI) | 325 | 1999-01-01 | 2014-12-19 |
| 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 Ketorolac Rinse - Leukoplakia, Periodontal Disease | Phase 2 | Completed | National Cancer Institute (NCI) | 57 | 1998-06-01 | 2008-03-04 |
Leukoplakia, Oral (14) · Erythroplasia (4) · Mouth Neoplasms (4) · Head and Neck Neoplasms (3) · Oropharyngeal Neoplasms (2) · Precancerous Conditions (2) · Squamous Cell Carcinoma of Head and Neck (2) · Tongue Neoplasms (2) · Actinic cheilitis (1) · Carcinoma in Situ (1) · Hyperplasia (1) · Hypopharyngeal Neoplasms (1) · Leukokeratosis, Hereditary Mucosal (1) · Lichen Planus, Oral (1)
Neoplasms (19) · Pathological Conditions, Anatomical (19) · Pathological Conditions, Signs and Symptoms (19) · Precancerous Conditions (17) · Mouth Diseases (15) · Stomatognathic Diseases (15) · Neoplasms by Site (14) · Head and Neck Neoplasms (11) · Mouth Neoplasms (10) · Carcinoma (2) · Carcinoma, Squamous Cell (2) · Neoplasms by Histologic Type (2) · Neoplasms, Glandular and Epithelial (2) · Otorhinolaryngologic Diseases (2)
Metformin (3) · Aminolevulinic Acid (2) · Pioglitazone (2) · Biopsy (1) · Celecoxib (1) · Dihematoporphyrin Ether (1) · Gels (1) · Imiquimod (1) · Nivolumab (1) · Photochemotherapy (1) · Rosiglitazone (1) · Specimen Handling (1) · calcipotriene (1) · pembrolizumab (1)
National Cancer Institute (NCI) (6) · Alexandria University (1) · Cairo University (1) · Dana-Farber Cancer Institute (1) · Fox Chase Cancer Center (1) · Instituto Nacional de Cancer, Brazil (1) · Jonsson Comprehensive Cancer Center (1) · University of Arizona (1) · University of Arkansas (1) · University of Massachusetts, Boston (1) · University of Medicine and Dentistry of New Jersey (1) · University of Miami (1) · University of Minnesota (1) · University of Southern California (1)
United States (15) · Canada (3) · Egypt (2) · India (1) · Italy (1)
Frank Ondrey (2) · Scott M Lippman (2) · Deborah Wong (1) · Eglal M Moussa, PhD oral medicine (1) · Francisco Civantos, Jr., MD (1) · Frank Meyskens (1) · Gal Shafirstein, PhD (1) · Glenn Hanna, MD (1) · Jay Boyle (1) · Jonathan Celli, PhD (1) · Mohammad Akram, MD (1) · Moni A Kuriakose, MD (1) · Paul F. Engstrom, MD (1) · Powel H. Brown (1) · Susan Goodin, PharmD (1)
PMID 39532605, PMID 39584361, PMID 14520092, PMID 22106236, PMID 23055220, PMID 23639862, PMID 34255745, PMID 37971722
N01CN35159 (2), P30CA016672 (2), P30CA023074 (2), N01CN00031 (1), N01CN35153 (1), P30CA008748 (1), U01CA072294 (1), U01CA279862 (1), UG1CA242596 (1)