3 completed, 2 terminated, 2 withdrawn, 1 recruiting. 8 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 3, Terminated 2, Withdrawn 2, Recruiting 1 |
| Phase 2 | 2 | Completed 1, 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 |
|---|---|---|---|---|---|---|
| Fenretinide Mucoadhesive Patch: Evaluation of Oral Cancer Prevention Efficacy in Adults With Premalignant Oral Lesions. Mucoadhesive fenretinide-releasing system (FMS) - Oral Leukoplakia, Oral Dysplasia | Phase 1 | Completed | Ohio State University Comprehensive Cancer Center | 7 | 2025-10-14 | 2026-09-25 |
| 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 |
| Intralesional 5-fluorouracil Injection for the Treatment of Oral Leukoplakia 5-fluorouracil - Oral Leukoplakia | Phase 1 | Withdrawn | University of California, San Francisco | 2022-09-30 | 2022-09-22 | |
| Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions Metformin, Biopsy - Erythroplakia, Leukoplakia | Phase 1 | Terminated | Thomas Jefferson University | 4 | 2022-05-04 | 2025-05-15 |
| This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions SBS-101, Placebo - Leukoplakia, Oral | Phase 1 | Withdrawn | Skyline Biosciences | 2022-01-01 | 2021-10-19 | |
| Aspirin Mouthwash in Treating Patients With Oral Leukoplakia acetylsalicylic acid, gene expression analysis, protein expression analysis - Precancerous Condition | Phase 1 | Completed | Institute of Head and Neck Studies and Education, United Kingdom | 40 | 2010-02-01 | 2013-08-12 |
| Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia aminolevulinic acid hydrochloride, photodynamic therapy, laboratory biomarker analysis - Oral Leukoplakia | Phase 1 | Terminated | National Cancer Institute (NCI) | 15 | 2008-03-01 | 2014-10-09 |
| 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 |
Leukoplakia, Oral (5) · Erythroplasia (3) · Leukokeratosis, Hereditary Mucosal (1) · Mouth Neoplasms (1) · Precancerous Conditions (1)
Neoplasms (8) · Pathological Conditions, Anatomical (8) · Pathological Conditions, Signs and Symptoms (8) · Precancerous Conditions (7) · Head and Neck Neoplasms (6) · Mouth Diseases (6) · Neoplasms by Site (6) · Stomatognathic Diseases (6) · Mouth Neoplasms (5) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1) · Genetic Diseases, Inborn (1) · Skin Diseases (1) · Skin Diseases, Genetic (1) · Skin and Connective Tissue Diseases (1)
Aminolevulinic Acid (2) · Biopsy (2) · 1-phenyl-3,3-dimethyltriazene (1) · Aspirin (1) · Fluorouracil (1) · Gene Expression Profiling (1) · Imiquimod (1) · Metformin (1) · Photochemotherapy (1)
Institute of Head and Neck Studies and Education, United Kingdom (1) · National Cancer Institute (NCI) (1) · Ohio State University Comprehensive Cancer Center (1) · Skyline Biosciences (1) · Thomas Jefferson University (1) · University of Arkansas (1) · University of California, San Francisco (1) · University of Southern California (1)
United States (7) · United Kingdom (1)
Gal Shafirstein, PhD (1) · Hisham Mehanna, MD (1) · Joy Schleyer (1) · Kyle Jones, DDS, PhD (1) · Susan R. Mallery, DDS, PhD (1) · Wong Stuart (1)
P30CA060553 (1), R01CA227273 (1)