Method: A randomized, double-blind, clinical trial was performed between August/2008 and August/2012. Adult patients with symptomatic oral lesions of cGVHD were included in the study. Patients were excluded if they had history of allergy to any medication of the protocol, or were already under topical treatment for oral cGVHD lesions. Patients were randomized into topical treatment either with clobetasol propionate 0.05%, or with dexamethasone 0.1 mg/mL. Patients were instructed to use 5 mL of the solution, 3 times a day, for 28 days. Oral lesions were diagnosed according to the NIH criteria, and graded according to the modified Oral Mucositis Rating Scale. Symptoms were analyzed through visual analogue scale. For statistical analysis, an intention to treat analysis was performed, at a significance level of 95%.
Result: A total of 35 patients were recruited, with 32 patients enrolled to the study groups: 14 (43,80%) men and 18 (56,30%) women. There was a significant symptomatic improvement in both groups. Clobetasol was associated to lower scores of lichen-type hyperkeratosis, ulcers and mOMRS total score, at the end of the treatment. Patients treatedwith clobetasol presented less mucoceles than those treated with dexamethasone. When patients without systemic treatment were separately analyzed, there were no significant symptomatic and morphologic response.
Conclusion: Clobetasol was more effective than dexamethasone in the symptomatic and morphologic improvement of oral cGVHD, but the influence of systemic imunossupressive therapy could not be eliminated in this study.