Oral Ulcer Clinical Trial
Official title:
Lenalidomide in the Treatment of Mucosal Behçet's Syndrome
The study is to evaluate the efficacy and safety of lenalidomide in the treatment of oral ulcers in adult patients with refractory mucosal Behcet's syndrome.
Behçet's Syndrome (BS) is a systemic vasculitis involving blood vessels of all sizes. It is characterised by recurrent oral and genital ulcers, skin lesions, musculoskeletal, ophthalmic, large vessel and intestinal involvements. Mucosal BS is the most common phenotype of BS, commonly treated with thalidomide and colchicine, yet some patients respond poorly or had limited use due to side effects. Lenalidomide, a second-generation derivative of thalidomide, has a role as an angiogenesis inhibitor, an antineoplastic agent and an immunomodulator. Its neurotoxicity and reproductive toxicity are significantly reduced, and the ability of TNF-alpha inhibition is significantly increased. Reports on lenalidomide for refractory mucosal BS have been mostly case reports and preliminary studies, clinical trials are lacking. This is a single-centre, prospective, open-label, single-arm study to evaluate the efficacy and safety of lenalidomide in the treatment of refractory mucosal BS; with the rate of complete remission of oral ulcers in subjects at 12 weeks as the primary endpoint; partial remission of oral and genital ulcers, non-response rate and BS disease activity as secondary endpoints; and adverse events and newly-developed BS-related symptoms as safety endpoints. This study aims to enroll adult patients with refractory mucosal BS with a stable dosage of low-dose glucocorticoids and/or other conventional immunomodulators. All subjects will be treated with lenalidomide 10mg/day with regular follow-up, those having adverse effects will be evaluated by investigators and adjusted to 5mg/day if necessary, with glucocorticoids and immunosuppressive agents adjusted as needed. Each subject will complete a 12-week treatment period, followed by 4 weeks of observation after cessation of lenalidomide. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03239834 -
Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making
|
||
| Not yet recruiting |
NCT04989049 -
Therapeutic Effect of Folic Acid in Healing of Oral Ulcers
|
Early Phase 1 | |
| Completed |
NCT06379438 -
Treatment of Aphtous Ulcers With Photodynamic Therapy
|
N/A | |
| Withdrawn |
NCT02769494 -
The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer
|
Phase 3 | |
| Completed |
NCT05413096 -
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
|
Early Phase 1 | |
| Completed |
NCT03633292 -
Aloe Vera and Chlorhexidine Against Traumatic Oral Ulcers
|
Phase 4 | |
| Completed |
NCT00333749 -
The Effectiveness of Pasteurized Goat Milk in the Treatment of Childhood Oral Ulcer Diseases
|
Phase 1 | |
| Recruiting |
NCT04710888 -
Basil Extract (Ocimum Basilicum) in the Management of Recurrent Aphthous Stomatitis
|
Phase 2 | |
| Completed |
NCT05147376 -
Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances
|
Early Phase 1 | |
| Completed |
NCT04383236 -
Probiotic Lozenges for Treatment of Recurrent Aphthous Stomatitis
|
N/A | |
| Completed |
NCT03167632 -
Oral Ulcer Prevalence: Hospital-based Cross-sectional Study
|
N/A | |
| Enrolling by invitation |
NCT05288478 -
Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in People With Epidermolysis Bullosa.
|
Phase 2 | |
| Completed |
NCT05032248 -
Uses of Tacrolimus in Behcet Disease
|
N/A |