Pimecrolimus versus Placebo in Minor, Recurrent Aphthous Stomatitis: A Randomized Double-blind Controlled Trial
AbstractBackground: Oral aphthous is one of the most common oral mucosal inflammatory disorders which are very painful. There is no definite medical strategy up to now for aphthous treatment. Recently, some researchers have focused on immunomodulatory drugs such as tacrolimus and pimecrolimus in preventing aphthus recurrences. The aim of this study is to assess the effect of pimecrolimus cream against placebo in management of oral minor aphthous.Methods: The study is a randomized clinical trial, was done in “Shariati” hospital and Isfahan Skin Research Center. 62 patients with minor aphthuos were included and divided randomly to two groups (31 in each). In experimental group, pimecrolimus cream was applied for two weeks and cold cream for the same duration in control group. Patients were followed for 3 and one week; results were assessed in recovery after drug administration. Compared variables between two groups were including: the size of lesions, the time to recovery and pain intensity.Results: Results showed that mean size lesion in experimental and placebo group after complete recovery reduced (23.6 ±15.3 and 24.8 ±15 mm respectively) but it was not significant (P: 0.1). Mean time for recovery in both groups was 8±2.2 and 9.5±2.5 respectively which was significant in pimecrolimus treated patients (P: 0.014). Also mean degree for pain intensity measured by pain scale method was reduced significantly in test group (6 ± 1.2 before treatment and 5.3 ± 1.1 after treatment, P<0.001).Conclusion: This study stated that pimecrolimus cream has an appropriate effect in reduction of recovery time and pain in minor aphthous compared to placebo but more clinical studies are needed to better conclusion.
Shashy RG, Ridley MB. Aphthous Ulcers: A Difficult Clinical Entity. Am J Otolaryngol 2000; 121: 389-93.
Fishman HC. Practical therapy for aphthous stomatitis. Cutis 1985; 36:479- 80.
Dreizen S: Aphthous ulcers. Postgrad Med 1981; 69:158.
Rodu B, Mattingly G. Oral mucosal ulcers: Diagnosis and management. J Am Dent Assoc 1992; 123:83-86.
Scully C. Aphthous Ulceration. N Engl J Med 2006; 355:165-72.
Rogers RS. Recurrent aphthous stomatitis: Clinical characteristics and associated systemic disorders. Semin Cutan Med Surg 1997; 16:278-83.
Ship JA. Recurrent aphthous stomatitis: An update. Oral Surg Oral Med Oral Pathol 1996; 81:141-7.
Miller MF, Garfunkel AA, Ram CA, Ship II. The inheritance of recurrent aphthous stomatitis. Observations on susceptibility. Oral Surg Oral Med Oral Pathol 1980; 49(5): 409–12.
Ship II. Epidemiologic aspects of recurrent aphthous ulcerations. Oral Surg Oral Med Oral Pathor 1972; 33(3):400–6.
Crivelli MR, Aguas S, Adler I, Quarracino C, Bazerque P. Influence of socioeconomic status on oral mucosa lesion prevalence in schoolchildren. Community Dent Oral Epidemiol 1988; 16(1):58–60.
Scully C, Porter S. Oral mucosal disease: Recurrent aphthous stomatitis. Br J Oral Maxillofac Surg 2008;46:198–206.
Scheer M, Kawari-Mahmoodi N, Neugebauer J, Kübler AC. Pimecrolimus (Elidel) for therapy of lichen ruber mucosae Mund Kiefer Gesichtschir. 2006; 10(6):403-7.
Taylor LJ, Bagg J, Walker DM, Peters TJ. Increased production of tumour necrosis factor by peripheral blood leukocytes in patients with recurrent oral aphthous ulceration. J Oral Pathol Med 1992; 21:21–5.
Natah SS, Hayrinen-Immonen R, Hietanen J, et al. Increased density of lymphocytes bearing gamma/delta T-cell receptors in recurrent aphthousulceration (RAU). Int J Oral Maxillofac Surg 2000; 29: 375–80.
Babaee N, Zabihi E, Mohseni S, et al. Evaluation of the therapeutic effects of Aloe vera gel on minor recurrent aphthous stomatitis. Dent Res J 2012; 9(4): 381–5.
EI-Bataway MM, Bosseila MA, Mashaly HM, et al. Topical calcineurin inhibitors in atopic dermatitis: a systemicreview and meta-analysis. J Dermatol Sci 2009; 54:76–87.
Cook BA, Warshaw EM. Role of topical calcineurin inhibitors in the treatment of seborrheic dermatitis: a review of pathophysiology, safety, and efficacy. Am J Clin Dermatol 2009; 10: 103–18.
Sarifakioglu E, Gumus II. Efficacy of topical pimecrolimus in the treatment of chronic vulvar pruritus: a prospective case series. a non-controlled, openlabel study. J Dermatolog Treat 2006; 17: 276–8.
Chamsdavatchi C, Barikbin B, Shahram F, et al. Pimecrolimus versus placebo in genital aphthous ulcers of Behcet’s disease: a randomized double-blind controlled trial. Int J Rheum Dis 2010; 13: 253–8.
Kose O, Dinc A, Simsek I, et al. Randomized trial of pimecrolimus cream plus colchicine tables versus colchicines tablets in the treatment of genital ulcers in Behçet’s disease. Dermatology 2009; 218: 140–5.