30 completed, 11 recruiting, 8 unknown, 5 terminated. 19 Phase 2, 11 Not applicable, 8 Phase 1, 3 Phase 3, 1 Phase 4.
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 |
| AI-Assisted Endoscopy for Upper Aerodigestive Tract Lesions Upper Aerodigestive Tract Neoplasms, Upper AerodigestiveTract Cancer | Not yet recruiting | Istituto Italiano di Tecnologia | 283 | 2026-05-01 | 2026-05-19 | |
| Comparison of Topical Photodynamic Therapy With Topical Calcipotriol in Management of Oral Leukoplakia Non-invasive Photo Dynamic Therapy using LED of wavelength ranging from 630-660nm( Fluence 15 J/cm2) as light source and 2.5% TB as photosensitizer, Topical application of Calcipotriol ointment 0.005% twice a day for 4 weeks along with preventive and conventional therapy, Conventional non-invasive management : All subjects in the two groups will receive the same standard conventional non- invasive management advised for OL as per current scientific evidence - Oral Leukoplakia | Phase 3 | Not yet recruiting | Dr. Shalini Gupta | 166 | 2026-04-01 | 2026-03-06 |
| 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 |
| Evaluation of Artificial Intelligence in Diagnosis and Risk Assessment of Oral Potentially Malignant Disorders Toluidine blue staining of the lesion and cytological smears - Oral Lichen Planus, Oral Leukoplakia | Not yet recruiting | Ain Shams University | 120 | 2025-12-16 | 2026-01-06 | |
| Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment Coenzyme Q10 gel, Topical curcumin gel - Oral Leukoplakia | Not applicable | Recruiting | Alexandria University | 34 | 2025-11-25 | 2026-01-12 |
| 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 |
| 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 |
| Unveiling the Protein Expression Patterns in Oral Lichen Planus and Leukoplakia Through Comparative Salivary Proteomics Saliva, Oral Lichen Planus | Completed | Kocaeli University | 21 | 2024-12-25 | 2026-02-18 | |
| Artificial Intelligence Based Program to Classify Oral Cavity Findings Based on Clinical Image Analysis Artificial intelligence based program - Oral Cancer, Oral Lichen Planus | Completed | Cairo University | 241 | 2024-04-01 | 2025-06-04 | |
| SYsteMatical Trained learnIng aLgorithms for Oral carcInogenesiS Interpretation by Optical Coherence Tomography OCT (Optical Coherence Tomography) - Oral Squamous Cell Carcinoma, Oral Potentially Malignant Disorder | Recruiting | University of Palermo | 200 | 2024-03-13 | 2025-05-23 | |
| Analyzing Handprint Patterns to Predict Oral Cancer Risks: A Comparative Study Oral Leukoplakia | Unknown | King Khalid University | 160 | 2024-02-29 | 2024-02-21 | |
| Oral Cancer Screening for Early Detection of Premalignant Disorders (PMOD) Brush sampling - Mouth Neoplasms | Not applicable | Recruiting | Dalarna County Council, Sweden | 200 | 2023-08-01 | 2023-09-08 |
| Identification of Oral Lesions Through an Autofluorescence System Screening examination - Oral Leukoplakia, Autofluorescence | Not applicable | Completed | Federico II University | 200 | 2023-06-01 | 2026-09-02 |
| 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 |
| Evaluation of Oral Potentially Malignant Disorders (OPMDs) with STRATICYTE™ STRATICYTE™ Test - Mouth Diseases | Recruiting | Proteocyte Diagnostics Inc. | 180 | 2023-01-01 | 2024-11-07 | |
| Diagnostic Accuracy of lncRNA DQ786243 and miRNA146a in Saliva of Oral Potentially Malignant Lesions Real-time Polymerase Chain Reaction technique - Potentially Malignant Lesions, Oral Lichen Planus | Completed | Fayoum University | 45 | 2022-11-01 | 2023-09-13 | |
| 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 |
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Leukoplakia, Oral (46) · Mouth Neoplasms (19) · Lichen Planus, Oral (15) · Erythroplasia (12) · Mouth Diseases (5) · Precancerous Conditions (5) · Squamous Cell Carcinoma of Head and Neck (5) · Head and Neck Neoplasms (4) · Disease (3) · Hyperplasia (3) · Keratoderma, Palmoplantar, Epidermolytic (3) · Lichen Planus (3) · Oropharyngeal Neoplasms (3) · Tongue Neoplasms (3)
Pathological Conditions, Anatomical (64) · Pathological Conditions, Signs and Symptoms (64) · Neoplasms (62) · Precancerous Conditions (59) · Stomatognathic Diseases (52) · Neoplasms by Site (51) · Mouth Diseases (48) · Head and Neck Neoplasms (47) · Mouth Neoplasms (31) · Skin Diseases (22) · Skin and Connective Tissue Diseases (22) · Skin Diseases, Papulosquamous (17) · Lichenoid Eruptions (16) · Lichen Planus (14)
Biopsy (4) · Metformin (4) · Aminolevulinic Acid (3) · Photochemotherapy (3) · Pioglitazone (2) · 1-phenyl-3,3-dimethyltriazene (1) · 5-aminolaevulinic acid-n-pentylester (1) · Acyclovir (1) · Aspirin (1) · Behavior Therapy (1) · Catechin (1) · Celecoxib (1) · Dapsone (1) · Dihematoporphyrin Ether (1) · Ethanol (1)
National Cancer Institute (NCI) (8) · Cairo University (4) · Alexandria University (2) · Dalarna County Council, Sweden (2) · National Taiwan University Hospital (2) · Proteocyte Diagnostics Inc. (2) · Ain Shams University (1) · Albert Einstein College of Medicine (1) · All India Institute of Medical Sciences (1) · Association for the Japanese Academy of Maxillofacial Implants (1) · Beijing Stomatological Hospital, Capital Medical University (1) · Beni-Suef University (1) · Candela Corporation (1) · Dana-Farber Cancer Institute (1) · Dr. Shalini Gupta (1)
United States (30) · Egypt (7) · India (5) · Italy (5) · Canada (4) · Sweden (2) · Taiwan (2) · United Kingdom (2) · Austria (1) · Belgium (1) · China (1) · Germany (1) · Japan (1) · Spain (1) · Turkey (Türkiye) (1)
Frank Ondrey (2) · Scott M Lippman (2) · C. David Hansen, MD (1) · Chun-Pin Chiang, DMSc (1) · Deborah Wong (1) · Eglal M Moussa, PhD oral medicine (1) · Eva Szabo, M.D. (1) · Falk Wehrhan, MD, DMD (1) · Francisco Civantos, Jr., MD (1) · Frank Meyskens (1) · Gabriella Dvorak, PD, DMD, MD (1) · Gal Shafirstein, PhD (1) · Giovanni Lodi, PhD, DMD (1)
PMID 39532605, PMID 39584361, PMID 14520092, PMID 21430705, PMID 22106236, PMID 22264670, PMID 23055220, PMID 23639862, PMID 25681375, PMID 33605440, PMID 33813637, PMID 34255745, PMID 34541702, PMID 37971722, PMID 40973523, PMID 41054469
N01CN35159 (2), P30CA016672 (2), P30CA023074 (2), N01CN00031 (1), N01CN35153 (1), P30CA008748 (1), P30CA060553 (1), R01CA227273 (1), R01DC019357 (1), U01CA072294 (1), U01CA279862 (1), UG1CA242596 (1)