A randomized double-blind, positive-control trial of topical thalidomide in erosive oral lichen planus

doi:10.1016/j.tripleo.2010.03.034

Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology

Volume 110, Issue 2, August 2010, Pages 188-195

https://doi.org/10.1016/j.tripleo.2010.03.034 Get rights and content

Objective

The objective of this study was to evaluate the short-term efficacy and safety of topical thalidomide for erosive oral lichen planes (OLP) in a prospective randomized, positive-control, double-blind clinical trial.

Study design

Sixty-nine patients with erosive OLP received thalidomide 1% paste (n = 37) or dexamethasone 0.043% paste (n = 32) for 1 week. Patients without erosions after initial 1-week treatment were followed for recurrence, whereas those with ongoing erosions received an additional 3-week treatment. Outcome measures included size of erosive area, visual analog scale (VAS) scores, 3-month recurrence rates, and adverse effects at 1 year.

Results

After 1-week application, both groups showed significant reductions in erosive areas and VAS scores (P < .001). Complete healing occurred in 18 (54.5%) of 33 thalidomide-treated and 17 (56.7%) of 30 dexamethasone-treated patients. Erosive area size (P = .420) and VAS scores (P = .498) were similar between groups. After 1 month of treatment, 24 patients receiving thalidomide (66.7%) and 22 receiving dexamethasone (73.3%) fully healed. There was no difference between groups in recurrence at the 3-month follow-up. Only 2 patients in each group experienced discomfort with treatment, and no adverse reactions were observed over 1 year of follow-up.

Conclusion

Topical thalidomide appears as effective as dexamethasone for erosive OLP.

Section snippets

Participants

This prospective randomized, positive-control, double-blind trial was carried out in the Department of Oral Medicine, West China Hospital of Stomatology, Sichuan University, China. Eighty-nine patients were assessed according to the eligibility requirements. Thirteen of these did not meet the inclusion criteria, and 7 of those who met the inclusion criteria refused to participate in the trial. Therefore, 69 patients with clinically and histopathologically proven erosive OLP were consecutively

Participant flow

Sixty-nine patients, including 16 men (23.19%) and 53 women (76.81%), aged 26 to 60 years, were enrolled in the trial: 37 in the topical thalidomide group and 32 in the topical dexamethasone group. Four subjects in the topical thalidomide group did not complete the observation period. Two of them had severe influenza and required other drug therapy during the treatment, and another 2 discontinued the intervention themselves (1 because of no improvement of symptoms and 1 because of the

Discussion

Dexamethasone, a long-acting glucocorticoid, has been widely used as an anti-inflammatory agent for OLP and other mucocutaneous inflammatory conditions.⁹ Topical dexamethasone in aerosol, mouthwash, suspension, and ointment forms was shown to be clinically effective.36, 37 Rhodus et al.³⁸ observed that dexamethasone mouthwash significantly decreased the production of proinflammatory cytokines and gave satisfactory clinical outcomes in erosive OLP, and extensive clinical experience has shown

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As mucosal and cutaneous disease share the same molecular underpinning, there is considerable overlap in therapies used in experiments in both conditions. Agents such as sulfasalazine, azathioprine, hydroxychloroquine, mycophenolate mofetil, tumor necrosis factor–alfa inhibitors and other biologics, and topical thalidomide have been studied in oral and genital lichenoid inflammation and are of varying efficacy.39,42,44-47,112,125 Pharmacognosy-derived agents, such as purslane48 and curcuminoids,50 have been demonstrated to be clinically efficacious in oral LP, although an uptake in clinical practice following larger-scale studies has not yet materialized.
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En la presente revisión sistemática se analizaron 55 artículos estructurados sobre la eficacia terapéutica frente al dolor y a los signos clínicos del liquen plano oral (LPO). La búsqueda bibliográfica se elaboró siguiendo los criterios del sistema PRISMA, seleccionando los ensayos realizados mediante alguno de los siguientes diseños metodológicos: entre fármaco (principio activo) vs. mismo fármaco en diferente excipiente o concentración, fármaco vs. diferente principio activo, fármaco vs. fitoterapia y fármaco vs. tratamiento con fototerapia.
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Based on the results, an algorithm is proposed to guide the treatment of OLP in its atrophic and erosive clinical forms. The use of clobetasol propionate at 0.025-0.05% of topical application as the first therapeutic alternative is highlighted. Secondly, 0.1% tacrolimus and 1% pimecrolimus also formulated for its topical regimen. And finally, we address the use of systemic corticosteroids and the application of diode lasers.
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: This study was supported by grants from the National Natural Science Foundation of China (No. 30872873, 30973311) and the Program for New Century Excellent Talents in University (No. NCET-07-0591).

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Oral medicineA randomized double-blind, positive-control trial of topical thalidomide in erosive oral lichen planus

Objective

Study design

Results

Conclusion

Section snippets

Participants

Participant flow

Discussion

J Oral Maxillofac Surg

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

Br J Oral Maxillofac Surg

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

J Am Dent Assoc

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

Arch Oral Biol

Clin Immunol

Clin Ther

Respir Med

Clin Ther

Immunopharmacology

J Am Acad Dermatol

Lichen planus: review and update on pathogenesis

J Oral Pathol

Oral lichen planus: controversies surrounding malignant transformation

Oral Dis

Malignant transformation of oral lichen planus: a retrospective study of 23 cases

Quintissence Int

Molecular mechanisms of corticosteroid resistance

Chest

Clinical features associated with glucocorticoid receptor polymorphisms

Ann N Y Acad Sci

Generalized glucocorticoid resistance: clinical aspects, molecular mechanisms, and implications of a rare genetic disorder

J Clin Endocrinol Metab

Oral medicine
A randomized double-blind, positive-control trial of topical thalidomide in erosive oral lichen planus