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Acitretin and treatment of the oral leucoplakias. A model to have an active molecules release
Author(s) -
Gaeta Gm,
Gombos F,
Femiano F,
Battista C,
Minghetti P,
Montanari L,
Satriano Ra,
Argenziano G
Publication year - 2000
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1046/j.1468-3083.2000.00155.x
Subject(s) - acitretin , medicine , saliva , gastroenterology , group b , placebo , randomized controlled trial , pharmacology , dermatology , pathology , psoriasis , alternative medicine
Aims The aim of this study was to investigate the effectiveness of acitretin in a new topical formulation (mucoadhesive two‐layer tablets) for the treatment of oral leucoplakias. Methods Twenty‐one volunteers, 16 men, five women, with oral leucoplakia (histologically diagnosed), were included in this double‐blind placebo‐controlled study. Patients were randomized in three groups (A, B, C) of seven patients each. Groups A and B received tablets with different in vitro release profiles, and group C subjects (controls) received tablets without acitretin. The acitretin dose was 20 mg/day (two 10 mg tablets daily). Serum aspartate aminotransferase, alanine aminotransferase, cholesterol and triglycerides were evaluated before and after treatment. At the end of therapy the concentrations of acitretin in plasma, saliva and tissue were measured by high‐performance liquid chromatography. Results At the end of the study 71% (groups A and B) of patients showed clinical remission or marked improvement. No improvement was noted in the control subjects (group C). These results were further confirmed by histological findings. There were no significant changes in laboratory values in the three groups. The acitretin concentration in plasma and tissue ranged from 0 to 50 mg with no difference between groups A and B, and it was very high in saliva (ranging from 4.9 to 43 mg) with higher concentrations in group A than in group B (due to a longer adhesion time in group A). Patients’ compliance was excellent. The results show that mucoadhesive tablets of topical acitretin are efficacious in the treatment of oral leucoplakia without systemic side‐effects.